Identity
- Trade Name
- Precise Norm EUDAMED
- Device Name
- Precise Norm EUDAMED
- Model / Reference
- 6003 EUDAMED6000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172971151 EUDAMED08053172971144 EUDAMED
- Basic UDI-DI
- B-08053172971151 EUDAMEDB-08053172971144 EUDAMED
- EMDN Code
- W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Precise Norm 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-08053172971151 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (2)
- EUDAMED bacce700-21d8-4b11-a6e9-4e360189181e 61 fields · synced Jul 11, 2026
- EUDAMED 5e68e979-3ec8-4b84-af05-a7e4ad7fb227 61 fields · synced May 17, 2026