← Back to catalogue
Sodio - Biotecnica Systems
EUDAMEDClass IVD General (EU MDR)
Ref BT0237Ref 0237Ref 0237/2
Identity
- Trade Name
- Sodio - Biotecnica Systems EUDAMEDSodio EUDAMED
- Device Name
- Sodio/Sodium - Biotecnica Systems EUDAMEDSodio/Sodium EUDAMED
- Model / Reference
- BT0237 EUDAMED0237 EUDAMED0237/2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172972813 EUDAMED08053172970819 EUDAMED08053172970826 EUDAMED
- Basic UDI-DI
- B-08053172972813 EUDAMEDB-08053172970819 EUDAMEDB-08053172970826 EUDAMED
- EMDN Code
- W01010309 SODIUM 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
Sodio - 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-08053172972813 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED 70fc148b-d791-4b26-8468-14053c57e02f 61 fields · synced Jul 31, 2026
- EUDAMED f6d2aec8-3813-409c-ae48-3af95fba73c9 61 fields · synced May 17, 2026
- EUDAMED df90b428-6c67-4643-872c-7532b61ecc2f 61 fields · synced May 18, 2026