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Bilirubina Totale (DPD) - Biotecnica systems
EUDAMEDClass IVD General (EU MDR)
Ref BT0034
Identity
- Trade Name
- Bilirubina Totale (DPD) - Biotecnica systems EUDAMED
- Device Name
- Bilirubina Totale/Total Bilirubin (DPD) - Biotecnica systems EUDAMED
- Model / Reference
- BT0034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172972998 EUDAMED
- Basic UDI-DI
- B-08053172972998 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN 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
Bilirubina Totale (DPD) - 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-08053172972998 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (1)
- EUDAMED 4fb8f25b-7d24-4e99-8119-343585d8226f 61 fields · synced Jul 19, 2026