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2,301 results · 39ms · Sources: EU EUDAMED, US FDA

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FDA UDI 1k FDA registration 339 FDA Pre-Market Approval 328 Device 169 FDA 510(k) 97 Basic UDI-DI 64 Manufacturer 21 Importer 11 Authorized representative 4 Certificate 4 FDA classification 4 System producer 1 + More Filters

Country

United States 2k Germany 186 Türkiye 78 United Arab Emirates 56 China 36 Israel 28 Italy 16 Switzerland 13 South Korea 11 Poland 10 Hong Kong 9 France 8 Uruguay 7 Australia 5 United Kingdom 5 Belgium 2 Japan 2 Pakistan 2 Taiwan 2 Argentina 1 + More Countries

Manufacturer

Pfm Medical Gmbh 84 Sayan Tıbbi Aletler Paz. San. Ve Tic. Ltd. şti. 30 Pfm Medical Mepro Gmb H 28 Pfm Medical Hico Gmb H 27 Shanghai Pz Medical Technology Co., Ltd. 22 Tuna Dis Tic. Ve Paz. Ltd. Sti 10 Pz Cormay Spółka Akcyjna 9 Zhengzhou Pz Laser Slim Technology Co., Ltd. 6 Etablissements Franco Et Fils 5 Pfm Medical Titanium Gmb H 4 Pfm Medical Cpp 4 Beijing Adss Development Co., Ltd 3 Feather Safety Razor Co., Ltd. 3 Beijing Nubway S&T Co., Ltd. 2 Besmed Health Business Corp. 2 Daddy D Pro 2 Hasa Optix 2 Meinntech Co., Ltd. 2 Shenzhen Mindray Bio Medical Electronics Co., Ltd. 2 Pfm Medical Inc. 2 + More Manufacturers

Competent Authority

De/Ca21 Bezirksregierung Köln Dezernat 24 122 Turkish Medicine And Medical Devices Agency 57 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 29 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 27 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 10 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 6 De/Ca304 Marktüberwachung Medizinprodukte Bayern 6 Ministry Of Health, Welfare And Sports 4 De/Ca38 Regierungspräsidium Karlsruhe 2 Federal Agency For Medicines And Health Products / / Health Products Division 2 Agencia Española De Medicamentos Y Productos Sanitarios 1 De/Ca18 Bezirksregierung Arnsberg 1 De/Ca23 Regierungspräsidium Darmstadt Dezernat Iv/Da 45.2 1 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 1 De/Ca37, Regierungspräsidium Stuttgart 1 De/Ca39, Regierungspräsidium Freiburg Referat 25 1 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 + More Competent Authorities

Kind

Single Use 28 Sterile 27 Reusable 26 Sterilization 19 Active 14 Measuring Function 13 Instrument 3 Professional Testing 3 Administering Medicine 2 Animal Tissues 1 Implantable 1 Kit 1 New Device 1 Reagent 1 Software 1 + More Kinds

Classification

FDA Class 3 329 Eu Ivd Class A 94 FDA Class 2 91 Eu Md Class 2a 68 Eu Md Class 1 58 Eu Md Class 2b 11 FDA Class 1 8 Eu Ivd Class B 2 FDA Unclassified 1 + More Classifications

Notified Body

Szutest Uygunluk Değerlendirme A.ş. 19 Tüv Süd Product Service Gmb H 3 Dekra Certification B.V. 2 Mtic Inter Cert S.R.L. 2 Notice Belgelendirme, Muayene Ve Denetim Hizmetleri Anonim şirketi 2 + More Notified Bodies

FDA FEI Number

1721676 278 2011171 219 1721504 195 2017233 194 3003094851 193 3006950086 193 3012536737 193 3015309643 193 1721686 171 2020394 171 3002504068 171 3002806368 171 3002807111 171 3033589330 171 3004426659 94 3009183442 94 1220477 57 3014233026 56 2183744 55 2126670 44 + More FDA FEI Numbers

Regulation

Us FDA 2k Eu Mdr 98 Eu Ivdr 96 Eu Mdd 39 + More Regulations

Authorized Representative

Shanghai International Holding Corp. Gmb H(europe) 26 Pfm Medical Ag 3 Pfm Medical Gmbh 3 Antex Medi Solution 2 Casus Europe B.V. 2 Mdi Europa Gmb H 2 Derungs Medical Gmb H 1 Herbert Waldmann Gmb H & Co. Kg 1 Immucor Medizinische Diagnostik Gmb H 1 Instrumentation Laboratory Sp A 1 Lotus Nl B.V. 1 Med Path Gmb H 1 Pride Mobility Products Europe Bv 1 + More Authorized Representatives

FDA Registration Number

1721676 278 2011171 219 1721504 195 2017233 194 1724474 193 3006950086 193 3012536737 193 3015309643 193 1721686 171 2020394 171 3002504068 171 3005941719 171 3033589330 171 9681442 171 3004426659 94 3009183442 94 1220477 57 3014233026 56 2183744 55 2126670 44 + More FDA Registration Numbers

FDA K Number

K020823 1 K021081 1 K092283 1 K111013 1 K782046 1 K790709 1 K790720 1 K803272 1 K812821 1 K822254 1 K940422 1 K955906 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 24 Mdd Annex V 2 Mdr Qms 2 + More Certificate Types

Status

On The Market 167 No Longer On The Market 2 + More Statuses

Shanghai International Holding Corp. GmbH(Europe)

Authorized representative

🇩🇪 Germany·637 Manufacturers·33064 Devices

<1 …112 113 114 115 116 >

Data last updated 04 / 2026. Visit the official EUDAMED website for up-to-date data.

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EU MDR

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EU IVDR

EU IVDR In Vitro Diagnostic Devices EU IVDR Class A In Vitro Diagnostic Devices EU IVDR Class A Software Devices EU IVDR Class B In Vitro Diagnostic Devices EU IVDR Class B Software Devices EU IVDR Class C In Vitro Diagnostic Devices EU IVDR Class C Software Devices EU IVDR Class D In Vitro Diagnostic Devices EU IVDR Class D Software Devices EU IVDR Instrument Devices EU IVDR Kit Devices EU IVDR Reagent Devices EU IVDR Software Devices

FDA

FDA Medical Devices FDA Class I Medical Devices FDA Class II Medical Devices FDA Class III Medical Devices

By Country

EU IVDR Medical Devices from China EU IVDR Medical Devices from France EU IVDR Medical Devices from Germany EU IVDR Medical Devices from Romania EU IVDR Medical Devices from United States EU MDR Medical Devices from China EU MDR Medical Devices from Egypt EU MDR Medical Devices from Finland EU MDR Medical Devices from France EU MDR Medical Devices from Germany EU MDR Medical Devices from Italy EU MDR Medical Devices from Pakistan EU MDR Medical Devices from Poland EU MDR Medical Devices from Spain EU MDR Medical Devices from Türkiye EU MDR Medical Devices from United Kingdom EU MDR Medical Devices from United States

Notified Bodies

BSI Group The Netherlands B.V. DEKRA Certification B.V. DNV Product Assurance AS POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. SGS Belgium NV TÜV Rheinland LGA Products GmbH TÜV SÜD Product Service GmbH UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

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