Identity
- Trade Name
- GGT EUDAMED
- Device Name
- GGT EUDAMED
- Model / Reference
- OSR6620 EUDAMEDOSR6020 EUDAMEDOSR6120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590060190 EUDAMED15099590000158 EUDAMED15099590010188 EUDAMED
- Basic UDI-DI
- 150995902OSR6620N5 EUDAMED150995902OSR6020M7 EUDAMED150995902OSR6120MC 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 — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, reagent.
- Gamma-GT (IFCC) — Thermo Fisher Scientific Oy · Class B
- Gamma-Glutamyl Transferase Reagent — Beckman Coulter, Inc. · IVD General
- γ - Glutamyltransferase (GGT) – Liquizyme (9+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Ɣ- Glutamyl transferase (GGT) (4+1) — Kalians Corporation · IVD General
- Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand) — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
- Alinity — ABBOTT IRELAND · Class I
- 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 | 150995902OSR6620N5 | Class B | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (3)
- EUDAMED 1da6b6fd-9775-431e-a06b-be851981e9b4 61 fields · synced Jul 26, 2026
- EUDAMED 2bb168dd-7151-4de0-bd99-023c684be8cb 61 fields · synced May 18, 2026
- EUDAMED 0336eb2c-c9c7-4e95-b085-0cc70881fdd4 61 fields · synced May 19, 2026