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Gamma GT (IFCC) - Biotecnica Systems
EUDAMEDClass IVD General (EU MDR)
Ref BT0010
Identity
- Trade Name
- Gamma GT (IFCC) - Biotecnica Systems EUDAMED
- Device Name
- Gamma GT (IFCC) EUDAMED
- Model / Reference
- BT0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172972554 EUDAMED
- Basic UDI-DI
- B-08053172972554 EUDAMED
- EMDN Code
- W01010116 GAMMA GLUTAMYLTRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Gamma GT (IFCC) - Biotecnica Systems by Giesse Diagnostics Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08053172972554 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (1)
- EUDAMED 9c923891-d282-4c70-bd50-0e6fae46c62b 61 fields · synced Jun 18, 2026