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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
- 06935740740708 EUDAMED06935740733168 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.
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- 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
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 (2)
- EUDAMED 8552889d-bf87-4796-a2b2-a11dcbe89859 61 fields · synced Oct 7, 2026
- EUDAMED 88a41df7-086b-4642-b145-e04a6f6b37c2 61 fields · synced May 18, 2026