7,313 results
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42ms
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Sources: EU EUDAMED, US FDA
EPT 0477.MDD.19/3104.1
Certificate
MDD Annex II (excluding section 4)·Labomar S.p.A.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI
1434-MDD-070/2021
Certificate
MDD Annex II (excluding section 4)·MEDI J Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs
Implant, Auditory Brainstem
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
FDA 510(k)
FDA Class 2
·Hematology
GCE, s.r.o.
Authorized representative
🇨🇿 Czechia·1 Manufacturer
V1 105961 0002
Certificate
IVDD Annex IV (excluding sections 4, 6)·Ace Medical Technology Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE
VeriSafe Compliance Limited
Authorized representative
🇮🇪 Ireland·1 Manufacturer
Spengler JT100 Control Solution (Level 2) (CE)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Tyson Bioresearch, Inc.·1 device
ENDOSHAFT-COVER® PLUS
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device
TRACHEO SET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Xmed-MF·1 device