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γ-Glutamyl Transferase Kit( IFCC Method)
EUDAMEDClass IVD General (EU MDR)
Ref 4432Model "R1：2x60ml R2:2x15ml "
Identity
- Trade Name
- γ-Glutamyl Transferase Kit( IFCC Method) EUDAMED
- Device Name
- γ-Glutamyl Transferase Kit( IFCC Method) EUDAMED
- Model / Reference
- "R1：2x60ml R2:2x15ml " EUDAMED4432 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565584433 EUDAMED
- Basic UDI-DI
- B-06977565584433 EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Category: Gamma-glutamyltransferase (GGT) IVD, reagent
γ-Glutamyl Transferase Kit( IFCC Method) by Coei Biotech Co.Ltd. — Class IVD General — IVDD — 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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06977565584433 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Coei Biotech Co.Ltd.
- EUDAMED SRN
- CN-MF-000049509
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED ca0be003-b2ef-46bd-9ca7-f37c287a8022 61 fields · synced Jul 10, 2026