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γ-Glutamyl Transferase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref GGT6011Y, GGT6012Y, GGT6013Y, GGT6014Y, GGT6015Y, GGT6011N, GGT6012N, GGT6013N, GGT6014N, GGT6015N
Identity
- Trade Name
- γ-Glutamyl Transferase Reagent Kit EUDAMED
- Device Name
- γ-Glutamyl Transferase Reagent Kit EUDAMED
- Model / Reference
- GGT6011Y, GGT6012Y, GGT6013Y, GGT6014Y, GGT6015Y, GGT6011N, GGT6012N, GGT6013N, GGT6014N, GGT6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GGT601BX EUDAMED
- Basic UDI-DI
- B-GGT601BX EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, reagent.
- GGT — BECKMAN COULTER IRELAND INC. · Class B
- 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
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-GGT601BX | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED 97285de9-5854-4d4a-8040-173a6f17bf5e 61 fields · synced Oct 7, 2026
- EUDAMED 97285de9-5854-4d4a-8040-173a6f17bf5e-1 61 fields · synced Jun 10, 2026
- EUDAMED 97285de9-5854-4d4a-8040-173a6f17bf5e-2 61 fields · synced Jun 10, 2026