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Bilirubina Diretta (DPD) - Biotecnica Systems
EUDAMEDClass IVD General (EU MDR)
Ref BT0033Ref 0032Ref 0032/2
Identity
- Trade Name
- Bilirubina Diretta (DPD) - Biotecnica Systems EUDAMEDBilirubina Diretta EUDAMED
- Device Name
- Bilirubina Diretta (DPD) - Biotecnica Systems EUDAMEDBilirubina Diretta/Direct Bilirubin EUDAMED
- Model / Reference
- BT0033 EUDAMED0032 EUDAMED0032/2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172972981 EUDAMED08053172970161 EUDAMED08053172970178 EUDAMED
- Basic UDI-DI
- B-08053172972981 EUDAMEDB-08053172970161 EUDAMEDB-08053172970178 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
Yes
EUDAMEDEUDAMED
Bilirubina Diretta (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-08053172972981 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED ae524b95-75b9-4c76-8802-b9ae5887d217 61 fields · synced Jul 25, 2026
- EUDAMED f4ee82ba-4797-4fbc-8e7f-66244c29f6f3 61 fields · synced May 17, 2026
- EUDAMED 08dc235b-f9fa-4435-b249-3159c3543114 61 fields · synced May 18, 2026