IMMUCOR, INC. - BEUDAMED

BEUDAMED

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421 results · 58ms · Sources: EU EUDAMED, US FDA

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FDA UDI 266 FDA registration 76 Basic UDI-DI 35 Device 35 FDA 510(k) 5 Manufacturer 2 Authorized representative 1 Certificate 1 + More Filters

Country

United States 420 Germany 1 + More Countries

Manufacturer

Immucor, Inc. 55 Immucor Gti Diagnostics, Inc 18 Bio Array Solutions Ltd 1 Dominion Biologicals Limited 1 + More Manufacturers

Competent Authority

De/Ca23 Regierungspräsidium Darmstadt Dezernat Iv/Da 45.2 74 + More Competent Authorities

Kind

Professional Testing 35 Reagent 32 Animal Tissues 13 Human Tissues 7 Instrument 2 Kit 2 New Device 1 Software 1 + More Kinds

Classification

Eu Ivd Class C 40 Eu Ivd Class A 30 FDA Class 2 5 + More Classifications

Notified Body

Tüv Rheinland Lga Products Gmb H 2 + More Notified Bodies

FDA FEI Number

1034569 60 2183608 21 1217183 2 2245451 2 3002806557 2 3003565434 2 3004434070 2 3037000637 2 + More FDA FEI Numbers

Regulation

Us FDA 347 Eu Ivdr 70 + More Regulations

Authorized Representative

Immucor Medizinische Diagnostik Gmb H 73 + More Authorized Representatives

FDA Registration Number

1034569 60 2183608 21 1217183 2 2245451 2 3004434070 2 3037000637 2 9610746 2 9710666 2 + More FDA Registration Numbers

Certificate Type

Ivdr Qms 2 + More Certificate Types

Status

On The Market 35 + More Statuses

HX 1804149-1

IVDR QMS·Immucor GTI Diagnostics, Inc·TÜV Rheinland LGA Products GmbH

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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

EU MDR Medical Devices EU MDR Active Medical Devices EU MDR Class I Medical Devices EU MDR Class I Software Devices EU MDR Class IIa Medical Devices EU MDR Class IIa Software Devices EU MDR Class IIb Medical Devices EU MDR Class IIb Software Devices EU MDR Class III Medical Devices EU MDR Class III Software Devices EU MDR Implantable Medical Devices EU MDR Measuring Function Medical Devices EU MDR Software Medical Devices

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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