9,442 results
·
49ms
·
Sources: EU EUDAMED, US FDA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
Phlecs full body blue
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Phlecs B.V.·1 device
Disposable HI-FLOW Bubble humidifier 400cc, 6 psi
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Besmed Health Business Corp.·1 device
Disposable Bubble humidifier 400cc, 6psi, diffuser
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Besmed Health Business Corp.·1 device
Disposable Bubble humidifier 400cc, 6psi, decentralized diffuser
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Besmed Health Business Corp.·1 device
Disposable Bubble humidifier 400cc, 6 psi
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Besmed Health Business Corp.·1 device
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit
G1 092582 0009
Certificate
MDD Annex II (excluding section 4)·Xuzhou Yongkang Electronic Science Technology Co., Ltd.·TÜV SÜD Product Service GmbH·18 Basic UDI-DIs
NuGrip CMC
FDA UDI
Smith & Nephew, Inc.·00885556857663·CMC DISPOSABLE PACK FOR STRYKER
NuGrip CMC
FDA UDI
Smith & Nephew, Inc.·00885556857656·CMC DISPOSABLE PACK FOR LINVATEC/HALL
Ascension MCP Joint Replacement
FDA UDI
Smith & Nephew, Inc.·00885556856833·MCP DISPOSABLE PACK FOR LINVATEC/HALL
Ascension MCP Joint Replacement
FDA UDI
Smith & Nephew, Inc.·00885556856840·MCP DISPOSABLE PACK FOR STRYKER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC)
HaB GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·2 Devices
Vacuum tube
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·HBH BIOTECHNOLOGY LIMITED·1 device
Vacuum tube
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·HBH BIOTECHNOLOGY LIMITED·1 device
Vacuum tube
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·HBH BIOTECHNOLOGY LIMITED·1 device
Vacuum tube
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·HBH BIOTECHNOLOGY LIMITED·1 device
Vacuum tube
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·HBH BIOTECHNOLOGY LIMITED·1 device
Vacuum tube
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·HBH BIOTECHNOLOGY LIMITED·1 device