<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810008950036</udiDi>
    <basicUdiDi>B-00810008950036</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Catheter 7mm</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-067-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:49.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950012</udiDi>
    <basicUdiDi>B-00810008950012</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Catheter 5mm</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-065-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:45.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950005</udiDi>
    <basicUdiDi>B-00810008950005</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-064-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:32.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729988</udiDi>
    <basicUdiDi>B-00810004729988</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Medium Ring Curette, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0901</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00584</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:31.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729810</udiDi>
    <basicUdiDi>B-00810004729810</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Small Ring Curette, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0901</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00564</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:30.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729759</udiDi>
    <basicUdiDi>B-00810004729759</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Dilator 2, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01340</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:27.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729742</udiDi>
    <basicUdiDi>B-00810004729742</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Dilator 1, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-00869</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:26.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729360</udiDi>
    <basicUdiDi>B-00810004729360</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Large Ring Curette, FH7 Endo</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0901</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00571</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:25.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729094</udiDi>
    <basicUdiDi>B-00810004729094</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>9mm Shaver, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01347</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:23.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729087</udiDi>
    <basicUdiDi>B-00810004729087</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>8mm Shaver, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01346</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:21.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729070</udiDi>
    <basicUdiDi>B-00810004729070</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>7mm Shaver, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01345</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:19.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729063</udiDi>
    <basicUdiDi>B-00810004729063</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tubular Retractor #3 - Beveled, 170mm, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1907</emdnCode>
    <emdnDescription>ARTHROSCOPIC SURGERY CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00503</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:19.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729056</udiDi>
    <basicUdiDi>B-00810004729056</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tubular Retractor #2 - Beaked, 170mm, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1907</emdnCode>
    <emdnDescription>ARTHROSCOPIC SURGERY CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00502</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:17.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729049</udiDi>
    <basicUdiDi>B-00810004729049</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tubular Retractor #1 - Beveled, 170mm, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1907</emdnCode>
    <emdnDescription>ARTHROSCOPIC SURGERY CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00501</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:15.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729025</udiDi>
    <basicUdiDi>B-00810004729025</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Expandable Shaver, Blade, FH7</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00257</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:13.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729018</udiDi>
    <basicUdiDi>B-00810004729018</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Expandable Shaver, FH7</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00256</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:12.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729001</udiDi>
    <basicUdiDi>B-00810004729001</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Disc Drill, 7.5mm, FH7</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00491</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:11.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004728929</udiDi>
    <basicUdiDi>B-00810004728929</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tubular Retractor #3 - Beveled,  140mm, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1907</emdnCode>
    <emdnDescription>ARTHROSCOPIC SURGERY CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00476</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:08.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004728912</udiDi>
    <basicUdiDi>B-00810004728912</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tubular Retractor #5 - Beaked, 140mm,  FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1907</emdnCode>
    <emdnDescription>ARTHROSCOPIC SURGERY CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00475</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:07.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004728905</udiDi>
    <basicUdiDi>B-00810004728905</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tubular Retractor #2 - Beaked, 140mm, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1907</emdnCode>
    <emdnDescription>ARTHROSCOPIC SURGERY CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00474</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:06.372Z</lastUpdated>
  </row>
</eudamedExport>