GHC - BEUDAMED

BEUDAMED

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4,141 results · 36ms · Sources: EU EUDAMED, US FDA

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FDA UDI 2k FDA registration 947 Device 299 Basic UDI-DI 285 FDA Pre-Market Approval 259 FDA 510(k) 190 Certificate 17 FDA classification 13 Manufacturer 10 Authorized representative 7 Importer 6 System producer 1 + More Filters

Country

United States 3k India 238 Germany 67 Japan 63 Canada 46 South Korea 23 China 21 Taiwan 16 Pakistan 14 France 13 United Kingdom 11 Mexico 10 Italy 7 Malaysia 7 Switzerland 7 Indonesia 6 Netherlands 6 Singapore 6 Belgium 2 Brazil 2 + More Countries

Manufacturer

Nagor Limited 492 Gpc Medical Limited 28 Ghc Co., Ltd. 14 Phc Corporation 13 Phc Corporation In Vitro Diagnostics Division 7 Acime Frame 5 Abon Biopharm(hangzhou) Co., Ltd 4 Gkc Manufacturing Pty. Ltd. 4 Besmed Health Business Corp. 3 Gc Medis Corp. 3 Ghc Global Health Care Gmb H 3 Seleo S.R.L. 3 Ageing Tech Srl 2 Dhc Innovations 2 Ge Healthcare 2 Groupe Sober Sas 2 Samphire Neuroscience Ltd 2 2nd Sight Medical Co.,Ltd. 1 3 D Biomedicine Science & Technology Co., Limited 1 Ankon Technologies Co., Ltd. 1 + More Manufacturers

Competent Authority

Health Products Regulatory Authority, Medical Devices Department 494 Ministry Of Health, Welfare And Sports 32 Agencia Española De Medicamentos Y Productos Sanitarios 28 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 17 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 11 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 5 Federal Agency For Medicines And Health Products / / Health Products Division 5 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 5 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 4 Cyprus Medical Devices Authority, Medical And Public Health Services, Ministry Of Health 3 The Medicines And Healthcare Products Regulatory Agency 3 National Agency For Medicines And Medical Devices Of Romania 2 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 1 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca39, Regierungspräsidium Freiburg Referat 25 1 Swedish Medical Products Agency 1 + More Competent Authorities

Kind

Sterile 262 Single Use 258 Implantable 181 Professional Testing 11 Sterilization 11 Orthopedic 10 Reagent 10 Active 7 Kit 7 Animal Tissues 6 Cmr Substance 5 Software 3 Measuring Function 2 Administering Medicine 1 Instrument 1 Latex 1 Near Patient Testing 1 + More Kinds

Classification

Eu Md Class 3 336 FDA Class 3 231 FDA Class 2 184 Eu Md Class 2a 170 FDA Class 1 42 Eu Md Class 1 31 Eu Md Class 2b 30 Eu Ivd Class A 10 Eu Ivd General 7 FDA Unclassified 1 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 493 Tüv Rheinland Lga Products Gmb H 6 Tüv Süd Product Service Gmb H 4 Dekra Certification B.V. 3 Bureau Veritas Italia S.P.A. 2 + More Notified Bodies

FDA FEI Number

2517506 509 3006513362 205 3002806559 161 2432235 158 3009189893 149 1000125183 147 3005333358 147 3015550354 141 3002809144 138 1000206808 136 1219913 126 3002806778 95 3003423869 95 3004140393 95 3004859032 95 3013059683 95 3006198300 94 1000306617 93 2122870 92 3002806944 91 + More FDA FEI Numbers

Regulation

Us FDA 4k Eu Mdd 489 Eu Mdr 78 Eu Ivdr 10 Eu Ivdd 7 + More Regulations

Authorized Representative

Gc Aesthetics (Management) Limited 493 Cmc Medical Devices & Drugs Sl 28 Phc Europe B.V. 21 Caretechion Gmb H 15 Medical Technology Promedt Consulting Gmb H 5 C Epartner4 U 4 Casus Europe B.V. 3 Global Regulatory Solutions Hc B.V. 3 Omc Ni Medical Limited 3 Obelis S.A. 3 Mdi Europa Gmb H 3 Ge Medical Systems Scs 2 Md Ti Cyprus Ltd 1 Termobit Prod Srl 1 Veranex Germany Gmb H 1 + More Authorized Representatives

FDA Registration Number

2517506 509 3006513362 205 9610126 161 2432235 158 3009189893 149 2028492 147 3005333358 147 3015550354 141 3002809144 138 9680746 136 1219913 126 3003423869 95 3004140393 95 3004859032 95 3013059683 95 9610099 95 3006198300 94 2029372 93 2122870 92 3002806944 91 + More FDA Registration Numbers

FDA K Number

Den160019 1 K001352 1 K001398 1 K050988 1 K071671 1 K080254 1 K102342 1 K111914 1 K120563 1 K130021 1 K131140 1 K142965 1 K212176 1 K782129 1 K790106 1 K790257 1 K791893 1 K800605 1 K800991 1 K800992 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii Section 4 347 Mdd Annex Ii (Excluding Section 4) 158 Ivdd Annex Iv (Excluding Sections 4, 6) 4 + More Certificate Types

Status

On The Market 297 Not Intended For Eu Market 2 + More Statuses

cottony II tape

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

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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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