<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05051223037576</udiDi>
    <basicUdiDi>B-05051223037576</basicUdiDi>
    <tradeName>Essential Insufflation Filter/Tubing Set with 15mm/22mm Connector</tradeName>
    <deviceName>Essential Insufflation Filter/Tubing Set with 15mm/22mm Connector</deviceName>
    <manufacturerName>SHANDONG ZHENFU MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031319</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0180</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3605A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:06.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223037569</udiDi>
    <basicUdiDi>B-05051223037569</basicUdiDi>
    <tradeName>Essential Insufflation Filter/Tubing Set with 15mm Connector</tradeName>
    <deviceName>Essential Insufflation Filter/Tubing Set with 15mm Connector</deviceName>
    <manufacturerName>SHANDONG ZHENFU MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031319</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0180</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3603A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:04.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223037552</udiDi>
    <basicUdiDi>B-05051223037552</basicUdiDi>
    <tradeName>Essential Insufflation Filter/Tubing Set with Push Fit Funnel Connector</tradeName>
    <deviceName>Essential Insufflation Filter/Tubing Set with Push Fit Funnel Connector</deviceName>
    <manufacturerName>SHANDONG ZHENFU MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031319</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0180</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3602A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:02.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223037545</udiDi>
    <basicUdiDi>B-05051223037545</basicUdiDi>
    <tradeName>Essential Insufflation Filter/Tubing Set with O Ring Connector</tradeName>
    <deviceName>Essential Insufflation Filter/Tubing Set with O Ring Connector</deviceName>
    <manufacturerName>SHANDONG ZHENFU MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031319</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0180</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3601A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:03:00.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223037538</udiDi>
    <basicUdiDi>B-05051223037538</basicUdiDi>
    <tradeName>Essential Insufflation Filter/Tubing Set with Luer Lock</tradeName>
    <deviceName>Essential Insufflation Filter/Tubing Set with Luer Lock</deviceName>
    <manufacturerName>SHANDONG ZHENFU MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031319</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K0180</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3600A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:59.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223033752</udiDi>
    <basicUdiDi>B-05051223033752</basicUdiDi>
    <tradeName>Dilating Tip Trocar, Smooth, 10x100mm</tradeName>
    <deviceName>Dilating Tip Trocar</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS4460ULTNS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:34.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031789</udiDi>
    <basicUdiDi>B-05051223031789</basicUdiDi>
    <tradeName>Secure Catch Plus Tissue Retrieval Pouch with Tail, 120 × 170mm</tradeName>
    <deviceName>Secure Catch Tissue Retrieval Pouch</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3406NS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:10.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031772</udiDi>
    <basicUdiDi>B-05051223031772</basicUdiDi>
    <tradeName>Secure Catch Plus Tissue Retrieval Pouch with Tail, 70 × 150mm</tradeName>
    <deviceName>Secure Catch Tissue Retrieval Pouch</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3405NS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:08.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031765</udiDi>
    <basicUdiDi>B-05051223031765</basicUdiDi>
    <tradeName>Secure Catch Tissue Retrieval Pouch, 175 × 220mm</tradeName>
    <deviceName>Secure Catch Tissue Retrieval Pouch</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3404NS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:06.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031758</udiDi>
    <basicUdiDi>B-05051223031758</basicUdiDi>
    <tradeName>Secure Catch Tissue Retrieval Pouch, 120 × 170mm</tradeName>
    <deviceName>Secure Catch Tissue Retrieval Pouches</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3403NS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:04.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031741</udiDi>
    <basicUdiDi>B-05051223031741</basicUdiDi>
    <tradeName>Secure Catch Tissue Retrieval Pouch, 70 × 150mm</tradeName>
    <deviceName>Secure Catch Tissue Retrieval Pouch</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3402NS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:03.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031727</udiDi>
    <basicUdiDi>B-05051223031727</basicUdiDi>
    <tradeName>12mm Sliding collar fixation device</tradeName>
    <deviceName>Fixation Device</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3462FNS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:02:02.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031635</udiDi>
    <basicUdiDi>B-05051223031635</basicUdiDi>
    <tradeName>AutoShield Trocar, Threaded,10x100mm</tradeName>
    <deviceName>Autoshield Trocar</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS5560ULTNS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:01:59.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031390</udiDi>
    <basicUdiDi>B-05051223031390</basicUdiDi>
    <tradeName>12mm Sliding collar fixation device</tradeName>
    <deviceName>Fixation Device</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3462F</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:01:58.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031079</udiDi>
    <basicUdiDi>B-05051223031079</basicUdiDi>
    <tradeName>Optical Cannula, 5 x 70mm</tradeName>
    <deviceName>Optical Cannula</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010103</emdnCode>
    <emdnDescription>OPTICAL TROCAR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS5537NS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:01:57.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031062</udiDi>
    <basicUdiDi>B-05051223031062</basicUdiDi>
    <tradeName>Optical Trocar, 5 x 70mm</tradeName>
    <deviceName>Optical Trocar</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010103</emdnCode>
    <emdnDescription>OPTICAL TROCAR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS5535NS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:01:55.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031055</udiDi>
    <basicUdiDi>B-05051223031055</basicUdiDi>
    <tradeName>Optical Cannula, 5 x 70mm</tradeName>
    <deviceName>Optical Cannula</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010103</emdnCode>
    <emdnDescription>OPTICAL TROCAR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS5537</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:01:53.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223031031</udiDi>
    <basicUdiDi>B-05051223031031</basicUdiDi>
    <tradeName>Optical Trocar, 5 x 70mm</tradeName>
    <deviceName>Optical Trocar</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010103</emdnCode>
    <emdnDescription>OPTICAL TROCAR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS5535</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:01:51.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223029007</udiDi>
    <basicUdiDi>B-05051223029007</basicUdiDi>
    <tradeName>Optical Cannula, 10 x 100mm</tradeName>
    <deviceName>Optical Cannula</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01010103</emdnCode>
    <emdnDescription>OPTICAL TROCAR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS5529</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:01:44.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051223028550</udiDi>
    <basicUdiDi>B-05051223028550</basicUdiDi>
    <tradeName>EndoRetrieval Pouch, 190 × 230 mm</tradeName>
    <deviceName>ULTIMATE ENDOSCOPIC TISSUE RETRIEVAL POUCHES</deviceName>
    <manufacturerName>Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000012819</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3444ULTNS</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:01:36.645Z</lastUpdated>
  </row>
</eudamedExport>