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γ - Glutamyltransferase (GGT) – Liquizyme (9+1)
EUDAMEDClass IVD General (EU MDR)
Ref 246 001Ref 246 003Ref 246 004
Identity
- Trade Name
- γ - Glutamyltransferase (GGT) – Liquizyme (9+1) EUDAMED
- Device Name
- γ - Glutamyltransferase (GGT) – Liquizyme (9+1) EUDAMEDγ-Glutamyltransferase (γ-GT)-Liquizyme (9+1) EUDAMED
- Model / Reference
- 246 001 EUDAMED246 003 EUDAMED246 004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041021270 EUDAMED62230041021416 EUDAMED62230041021584 EUDAMEDG4582460039F EUDAMED
- Basic UDI-DI
- B-62230041021270 EUDAMEDB-62230041021416 EUDAMEDB-62230041021584 EUDAMED++G458246N2 EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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 (GGT) – Liquizyme (9+1) by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDR, IVDD — 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
- 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
- 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
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-62230041021270 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-62230041021270 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 4db90bec-d370-4803-b4b4-f313fe7a769a 61 fields · synced Oct 6, 2026
- EUDAMED 36d762a0-9b90-4c10-bcbc-1555d95500af 61 fields · synced May 18, 2026
- EUDAMED a1192395-b50f-4242-af43-916c4008613c 61 fields · synced May 18, 2026
- EUDAMED 012955ca-d275-4b2b-bc38-39e9d5f925a7 61 fields · synced Jul 10, 2026