<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08436628290547</udiDi>
    <basicUdiDi>8437026387ECOS-INT2D</basicUdiDi>
    <tradeName>KIT ESTÁNDARD METAGENÓMICA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AYALA SAMPLE KITS, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000037853</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL017.2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:55.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832021473</udiDi>
    <basicUdiDi>849832002UH</basicUdiDi>
    <tradeName>LRSD-041 IP ActivFlo Biopsy I, Taped</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39LC-605-2-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:55.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436628290660</udiDi>
    <basicUdiDi>8437026387ECOS-INT2D</basicUdiDi>
    <tradeName>KIT ESTÁNDARD METAGENÓMICA RENNOVA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AYALA SAMPLE KITS, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000037853</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL017.3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:53.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437026387402</udiDi>
    <basicUdiDi>8437026387CAL0022F</basicUdiDi>
    <tradeName>KIT TOMA DE MUESTRA DE ORINA  PARA HISTAMINA Y METILHISTAMINA EN ORINA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AYALA SAMPLE KITS, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000037853</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:33.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832021480</udiDi>
    <basicUdiDi>849832002UH</basicUdiDi>
    <tradeName>IP ActivFlo Biopsy I, Taped, Aqua</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39LC-605-3-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:32.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437026387891</udiDi>
    <basicUdiDi>8437026387CAL0022F</basicUdiDi>
    <tradeName>KIT TOMA DE MUESTRA DE ORINA PARA ESTUDIO DE METABOLITOS ORGANICOS, MICOTOXINAS y/o PLAGUICIDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AYALA SAMPLE KITS, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000037853</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAL006.1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:30.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832021497</udiDi>
    <basicUdiDi>849832002UH</basicUdiDi>
    <tradeName>IP ActivFlo Biopsy I, Taped, Green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39LC-605-4-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:30.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832021503</udiDi>
    <basicUdiDi>849832002UH</basicUdiDi>
    <tradeName>IP ActivFlo Biopsy I, Taped, Lilac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39LC-605-5-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:26.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437026387310</udiDi>
    <basicUdiDi>8437026387SALUD-STZ</basicUdiDi>
    <tradeName>KIT TOMA DE MUESTRA PARA EL TEST  ETS HOMBRE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AYALA SAMPLE KITS, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000037853</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETSH-PAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:15.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437026387327</udiDi>
    <basicUdiDi>8437026387SALUD-STZ</basicUdiDi>
    <tradeName>KIT TOMA DE MUESTRA PARA EL TEST  ETS-HPV HOMBRE AUTOTOMA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AYALA SAMPLE KITS, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000037853</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SALXH-PAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:14.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832023361</udiDi>
    <basicUdiDi>849832034UW</basicUdiDi>
    <tradeName>Premier Cover Glass</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800151G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:14.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437026387341</udiDi>
    <basicUdiDi>8437026387SALUD-STZ</basicUdiDi>
    <tradeName>KIT TOMA DE MUESTRA PARA EL TEST Vv+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AYALA SAMPLE KITS, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000037853</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAG-PRF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:14.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437026387358</udiDi>
    <basicUdiDi>8437026387SALUD-STZ</basicUdiDi>
    <tradeName>KIT TOMA DE MUESTRA PARA EL TEST  Vv+ AUTOTOMA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AYALA SAMPLE KITS, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000037853</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAG-PAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:13.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>05608384015815</udiDi>
    <basicUdiDi>56083842800544Z</basicUdiDi>
    <tradeName>150ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ESTERIPLAS- PRODUTOS PARA A AREA DA SAUDE, LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000033228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100500280061</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:08.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832017797</udiDi>
    <basicUdiDi>849832034UW</basicUdiDi>
    <tradeName>Premier Cover Glass</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800160G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:02.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832022449</udiDi>
    <basicUdiDi>849832002UH</basicUdiDi>
    <tradeName>IP ActivFlo Routine I, Taped, Yellow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39LC-500-9-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:34.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832023392</udiDi>
    <basicUdiDi>849832003UK</basicUdiDi>
    <tradeName>XTRA Adhesive Microscope Slide - Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800202AE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:27.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832020834</udiDi>
    <basicUdiDi>849832002UH</basicUdiDi>
    <tradeName>IP ActivFlo Biopsy II, Taped, Tan</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39LC-610-10-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:26.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832023774</udiDi>
    <basicUdiDi>849832003UK</basicUdiDi>
    <tradeName>XTRA Adhesive Microscope Slides - Green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800203AE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:26.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>10849832020841</udiDi>
    <basicUdiDi>849832002UH</basicUdiDi>
    <tradeName>IP ActivFlo Biopsy II, Taped, Gray</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39LC-610-11-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:46:24.971Z</lastUpdated>
  </row>
</eudamedExport>