Identity
- Trade Name
- Albumina EUDAMED
- Device Name
- Albumina/Albumin EUDAMED
- Model / Reference
- 0027/2 EUDAMED0027 EUDAMED0028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172970000 EUDAMED08053172970017 EUDAMED08053172970024 EUDAMED
- Basic UDI-DI
- B-08053172970000 EUDAMEDB-08053172970017 EUDAMEDB-08053172970024 EUDAMED
- EMDN Code
- W01010201 ALBUMIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Albumina 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-08053172970000 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED 16fa4af3-c684-4234-a0ad-13f62179a78c 61 fields · synced Jul 27, 2026
- EUDAMED 2cae9d10-711b-4c71-a155-5413fb1a201a 61 fields · synced May 18, 2026
- EUDAMED bb9da46a-a65b-4b6a-a9c8-02ab798c283b 61 fields · synced May 18, 2026