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Ggt
EUDAMEDClass B (EU MDR)
Ref 1419-0100Ref 1418-0107Ref 1415-0102Ref 1516-0100
Identity
- Trade Name
- GGT EUDAMED
- Device Name
- GGT EUDAMED
- Model / Reference
- 1419-0100 EUDAMED1418-0107 EUDAMED1415-0102 EUDAMED1516-0100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309122912 EUDAMED05204309031290 EUDAMED05204309174164 EUDAMED05204309175307 EUDAMED
- Basic UDI-DI
- 5204309000024NQ EUDAMED
- Direct Marketing DI
- 05204309122912 EUDAMED05204309031290 EUDAMED05204309174164 EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Greece 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
Ggt by Medicon Hellas SA — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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
- 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 | 5204309000024NQ | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (4)
- EUDAMED f3633b22-5c9e-470f-881f-291ed4bc0a09 61 fields · synced Jul 30, 2026
- EUDAMED 804852b6-c4f0-48fb-9ef1-1eab4ca1deac 61 fields · synced May 17, 2026
- EUDAMED e093f409-2e45-41e3-9c6e-ef725ef4871c 61 fields · synced May 18, 2026
- EUDAMED ec4ade4d-be25-4802-87b5-8a2654eed34f 61 fields · synced May 18, 2026