Identity
- Trade Name
- Alfa Amilasi EUDAMED
- Device Name
- Alfa Amilasi/Alpha Amylase EUDAMED
- Model / Reference
- 5502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172970086 EUDAMED
- Basic UDI-DI
- B-08053172970086 EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL 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
Alfa Amilasi 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-08053172970086 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (1)
- EUDAMED 7eac39e7-32ac-4ff4-b93d-cd9e35f36f7b 61 fields · synced Jun 18, 2026