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Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand)
EUDAMEDClass B (EU MDR)
Ref 105-000856-00Model 105-000817-00、105-000856-00、105-004594-00Ref 105-004594-00
Identity
- Trade Name
- Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand) EUDAMED
- Device Name
- Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand) EUDAMED
- Model / Reference
- 105-000817-00、105-000856-00、105-004594-00 EUDAMED105-000856-00 EUDAMED105-004594-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904025124 EUDAMED06944904050720 EUDAMED
- Basic UDI-DI
- 694490400041GGT********JR 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
Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand) by Shenzhen Mindray Bio-Medical Electronics 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
- γ - Glutamyltransferase (GGT) – Liquizyme (9+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Ɣ- Glutamyl transferase (GGT) (4+1) — Kalians Corporation · IVD General
- Alinity — ABBOTT IRELAND · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- GAMMA GT-S Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- γ-Glutamyl Transferase Assay Kit (Rate Assay) — Da Te Bioengineering Technology Co., LTD. · 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 | 694490400041GGT********JR | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f955a464-5ea7-4333-aa62-75b56bf71f4f 61 fields · synced Jul 30, 2026
- EUDAMED cc77d32d-246a-48bb-991b-508fc2ae3311 61 fields · synced May 17, 2026