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Medical device companies in EUDAMED

Look up medical device manufacturers, authorised representatives, importers, and system producers registered worldwide.

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Medical device companies in Germany
Medical device companies in Italy
Medical device companies in France
Medical device companies in Netherlands
Medical device companies in Spain
Medical device companies in Poland

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Authorised representatives in EUDAMED
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Role

Economic entities

ManufacturerAuthorised representativeImporterSystem / procedure pack producer

Notified bodies

Competent authorities

Country

Europe

Åland IslandsAlbaniaAndorraAustriaBelarusBelgiumBosnia & HerzegovinaBulgariaCroatiaCyprusCzechiaDenmarkEstoniaFaroe IslandsFinlandFranceGermanyGibraltarGreeceGuernseyHungaryIcelandIrelandIsle of ManItalyJerseyLatviaLiechtensteinLithuaniaLuxembourgMaltaMoldovaMonacoMontenegroNetherlandsNorth MacedoniaNorwayPolandPortugalRomaniaRussiaSan MarinoSerbiaSlovakiaSloveniaSpainSvalbard & Jan MayenSwedenSwitzerlandUkraineUnited KingdomVatican City

Americas

AnguillaAntigua & BarbudaArgentinaArubaBahamasBarbadosBelizeBermudaBoliviaBrazilBritish Virgin IslandsCanadaCaribbean NetherlandsCayman IslandsChileColombiaCosta RicaCubaCuraçaoDominicaDominican RepublicEcuadorEl SalvadorFalkland IslandsFrench GuianaGreenlandGrenadaGuadeloupeGuatemalaGuyanaHaitiHondurasJamaicaMartiniqueMexicoMontserratNicaraguaPanamaParaguayPeruPuerto RicoSint MaartenSouth Georgia & South Sandwich IslandsSt. BarthélemySt. Kitts & NevisSt. LuciaSt. MartinSt. Pierre & MiquelonSt. Vincent & GrenadinesSurinameTrinidad & TobagoTurks & Caicos IslandsU.S. Virgin IslandsUnited StatesUruguayVenezuela

Asia

AfghanistanArmeniaAzerbaijanBahrainBangladeshBhutanBritish Indian Ocean TerritoryBruneiCambodiaChinaChristmas IslandCocos (Keeling) IslandsGeorgiaHong Kong SAR ChinaIndiaIndonesiaIranIraqIsraelJapanJordanKazakhstanKuwaitKyrgyzstanLaosLebanonMacao SAR ChinaMalaysiaMaldivesMongoliaMyanmar (Burma)NepalNorth KoreaOmanPakistanPalestinian TerritoriesPhilippinesQatarSaudi ArabiaSingaporeSouth KoreaSri LankaSyriaTaiwanTajikistanThailandTimor-LesteTürkiyeTurkmenistanUnited Arab EmiratesUzbekistanVietnamYemen

Africa

AlgeriaAngolaBeninBotswanaBouvet IslandBurkina FasoBurundiCameroonCape VerdeCentral African RepublicChadComorosCongo - BrazzavilleCongo - KinshasaCôte d’IvoireDjiboutiEgyptEquatorial GuineaEritreaEswatiniEthiopiaFrench Southern TerritoriesGabonGambiaGhanaGuineaGuinea-BissauKenyaLesothoLiberiaLibyaMadagascarMalawiMaliMauritaniaMauritiusMayotteMoroccoMozambiqueNamibiaNigerNigeriaRéunionRwandaSão Tomé & PríncipeSenegalSeychellesSierra LeoneSomaliaSouth AfricaSouth SudanSt. HelenaSudanTanzaniaTogoTunisiaUgandaWestern SaharaZambiaZimbabwe

Oceania

American SamoaAntarcticaAustraliaCook IslandsFijiFrench PolynesiaGuamHeard & McDonald IslandsKiribatiMarshall IslandsMicronesiaNauruNew CaledoniaNew ZealandNiueNorfolk IslandNorthern Mariana IslandsPalauPapua New GuineaPitcairn IslandsSamoaSolomon IslandsTokelauTongaTuvaluU.S. Outlying IslandsVanuatuWallis & Futuna

Country type

EU member stateNon-EUExtended EU

Status

ActiveInactive

Date of registration

AfterBefore

Nb devices

MinimumMaximum

Nb on-market devices

MinimumMaximum

Nb Basic UDI-DI

MinimumMaximum

Marketed countries

MinimumMaximum

Nb certificates

MinimumMaximum

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]AIMDD [Directive 90/385/EEC on active implantable medical devices]MDD [Directive 93/42/EEC on medical devices]IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Risk class

Class IClass IIaClass IIbClass IIIIVDR Class AIVDR Class BIVDR Class CIVDR Class DIVDD — GeneralIVDD — Annex II List AIVDD — Annex II List BIVDD — Self-testingAIMDD

Market country

AustriaBelgiumBulgariaCroatiaCyprusCzechiaDenmarkEstoniaFinlandFranceGermanyGreeceHungaryIcelandIrelandItalyLatviaLiechtensteinLithuaniaLuxembourgMaltaNetherlandsNorwayPolandPortugalRomaniaSlovakiaSloveniaSpainSwedenSwitzerlandUnited Kingdom

Medical domain

Administration, withdrawal & collectionCardiovascularSurgeryDentalDermatologyIn vitro diagnosticsVarious medical devicesGynaecology & obstetricsImaging & radiologyActive implantsNephrology & dialysisNeurologyOphthalmologyENT (ear, nose & throat)OrthopaedicsWound care & dressingsRespiratory & anaesthesiaUrologyOther

Issuing agency

GS1HIBCCEUDAMEDICCBBAIFA

Certificate type

Quality management systemTechnical documentationType examinationQuality assuranceProduct verificationQuality management systemTechnical documentationType examinationQuality assuranceProduction quality assurance

Notified body

NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390Schweizerische Vereinigung für Qualitäts- und ManagementsystemeENTE CERTIFICAZIONE MACCHINE SRLEVPU a.s.SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQBUREAU VERITAS ITALIA S.P.A.CESKY METROLOGICKY INSTITUTPOLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.SGS Belgium NVTURKISH STANDARDS INSTITUTION (TSE)Kiwa Assurance B.V.TUV Rheinland Italia SRLKiwa Belgelendirme Hizmetleri A.Ş.Szutest Uygunluk Değerlendirme A.Ş.3EC International a.s.TUV NORD Polska Sp. z o.oUDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.TÜV SÜD DanmarkDNV Product Assurance ASUDEM Adriatic d.o.o.Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim ŞirketiBSI Group The Netherlands B.V.HTCert (Health Technology Certification Ltd)bqs. s.r.o.Intertek Medical Notified Body ABCeCert Sp. z o.o.QMD Services GmbHSZUTEST Konformitätsbewertungsstelle GmbHSertio OyScarlet NB B.V.TÜV NORD Scandinavia Medical Notified Body ABNOTICE, storitve ugotavljanja skladnosti, d.o.o.Malta Conformity Assessment Ltd.TÜV NORD CERT GmbHNational Standards Authority of Ireland (NSAI)IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.MTIC InterCert S.r.l.BSI Assurance UK LtdSGS United Kingdom LimitedTÜV SÜD Product Service GmbHDEKRA Certification GmbHTÜV Rheinland LGA Products GmbHDQS Medizinprodukte GmbHCENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOSAFNOR CertificationDEKRA Certification B.V.ISTITUTO SUPERIORE DI SANITA'RISE Research Institutes of Sweden ABINTERTEK SEMKO ABICIM S.P.A.ITALCERT SRLGMED SASKIWA CERMET ITALIA S.P.A.Eurofins Product Testing Italy S.r.l.DNV MEDCERT GmbHmdc medical device certification GmbHSLG PRÜF UND ZERTIFIZIERUNGS GMBHEurofins Electric & Electronics Finland OyPresafe Denmark A/SCERTIQUALITY S.r.l.SGS FIMKO OYBerlin Cert GmbHNATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTYEurofins Product Service GmbHTHERAPEUTIC GOODS ADMINISTRATIONUL INTERNATIONAL (UK) LTD

Last update

AfterBefore

Results Found

10 companies match your query

Bi-trumed Biotech Co., Ltd.

CN-MF-000042268

Role

Manufacturer

Location

Jiaxing, CN

Status

Active

Date of registration

5/27/2024

Hangzhou Alltest Biotech.Co.,Ltd.

CN-MF-000010710

Role

Manufacturer

Location

Hangzhou, CN

Status

—

Date of registration

7/28/2021

Aceso Laboratories, Inc.

US-MF-000045175

Role

Manufacturer

Location

Chino, CA, US

Status

Active

Date of registration

11/21/2024

ACtest Biotech Co., Ltd.

CN-MF-000049724

Role

Manufacturer

Location

JiaXing, CN

Status

Active

Date of registration

9/26/2025

Acro Biotech Inc.

US-MF-000017832

Role

Manufacturer

Location

Montclair, US

Status

Active

Date of registration

12/9/2021

Rapid Labs Ltd

Rapid Labs

GB-MF-000026335

Role

Manufacturer

Location

Colchester, Essex, GB

Status

Active

Date of registration

7/22/2022

CITEST DIAGNOSTICS INC

CA-MF-000022516

Role

Manufacturer

Location

Vancouver, CA

Status

Active

Date of registration

4/7/2022

Newlink Biotech co., Ltd.

CN-MF-000045176

Role

Manufacturer

Location

Jiaxing, CN

Status

Active

Date of registration

11/21/2024

Hangzhou Aokai Biotech Co., Ltd.

CN-MF-000048311

Role

Manufacturer

Location

Hangzhou, CN

Status

Active

Date of registration

6/18/2025

Hangzhou Tongzhou Biotechnology Co., Ltd.

CN-MF-000038774

Role

Manufacturer

Location

Linping District, Hangzhou, CN

Status

Active

Date of registration

11/21/2023

FeaturedSchein Orthopädie Service KG

Most devices on the market · 58,355 devices on the market

FeaturedMedtronic, Inc.

Most certificates

FeaturedBeijing ZKSK

Most-followed manufacturer