Identity
- Trade Name
- GGT EUDAMED
- Device Name
- GGT EUDAMED
- Model / Reference
- OSR6120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590010188 EUDAMED
- Basic UDI-DI
- 150995902OSR6120MC EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Gamma-glutamyltransferase (GGT) IVD, reagent
Ggt by Beckman Coulter Ireland Inc. — Class B — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gamma-glutamyltransferase (GGT) IVD, reagent.
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- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- GAMMA GT-S Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995902OSR6120MC | Class B | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (1)
- EUDAMED 0336eb2c-c9c7-4e95-b085-0cc70881fdd4 61 fields · synced Oct 7, 2026