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