51 results · 8ms · Sources: EU EUDAMED, US FDA

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TruTORQ Large Engine Adaptor, 7 Nm

Device
EU MDR · Eu Md Class 2a ·ECA MEDICAL INSTRUMENTS·On the market·2 countries

GAP IgM Helicobacter pylori ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biomerica, Inc.·1 device

COVID-19 Ag and IgG/IgM Ab Combo Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·W.H.P.M. Bioresearch & Technology Co., Ltd.·1 device

COVID-19 Ag and IgG/IgM Ab(High Sensitivity) Combo Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·W.H.P.M. Bioresearch & Technology Co., Ltd.·1 device

TNP/MDR/0029/5488/2025

Certificate
MDR QMS·Cutera, Inc.·TUV NORD Polska Sp. z o.o

44232117851

Certificate
MDD Annex II (excluding section 4)·Cutera, Inc.·TÜV NORD CERT GmbH·16 Basic UDI-DIs

615075

Certificate
MDD Annex V·ElectroCore, Inc.·BSI Group The Netherlands B.V.·3 Basic UDI-DIs

571753

Certificate
MDD Annex II (excluding section 4)·ElectroCore, Inc.·BSI Group The Netherlands B.V.·41 Basic UDI-DIs

2797

Certificate
MDD Annex II (excluding section 4)·ElectroCore, Inc.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

35591

Certificate
MDD Annex II (excluding section 4)·Kurin, Inc.·GMED SAS·37 Basic UDI-DIs

0459

Certificate
MDD Annex II (excluding section 4)·Kurin, Inc.·GMED SAS·2 Basic UDI-DIs

35991

Certificate
MDD Annex II (excluding section 4)·Kurin, Inc.·GMED SAS·1 Basic UDI-DI

170683274

Certificate
MDD Annex II (excluding section 4)·OrthAlign, Inc·DQS Medizinprodukte GmbH·61 Basic UDI-DIs

CE 597147

Certificate
MDD Annex II (excluding section 4)·Opsens Inc.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

1434-MDD-033/2021

Certificate
MDD Annex II Section 4·Urotronic, Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·6 Basic UDI-DIs

1434-MDD-167/2020

Certificate
MDD Annex II (excluding section 4)·VitalConnect, Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

20560

Certificate
IVDD Annex IV (excluding sections 4, 6)·Biomerica, Inc.·GMED SAS·10 Basic UDI-DIs

29144

Certificate
MDD Annex II (excluding section 4)·Embolx, Inc.·GMED SAS·10 Basic UDI-DIs

CE 597148

Certificate
MDD Annex II (excluding section 4)·Opsens Inc.·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

28620177096

Certificate
MDR QMS·Amalgam Rx, Inc·Intertek Medical Notified Body AB