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γ-Glutamyltransferase Reagent Kit (GCANA Substrate Method)
EUDAMEDClass B (EU MDR)
Ref /
Identity
- Device Name
- γ-Glutamyltransferase Reagent Kit (GCANA Substrate Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740733175 EUDAMED
- Basic UDI-DI
- 69357407ICAS000016AV EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
γ-Glutamyltransferase Reagent Kit (GCANA Substrate Method) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED
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
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- 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 | 69357407ICAS000016AV | Class B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b24d5ace-f34f-4fc6-b8d8-605aefbde0d1 61 fields · synced Jun 19, 2026