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Colesterolo Totale
EUDAMEDClass IVD General (EU MDR)
Ref 0045Ref 0035Ref BT0035
Identity
- Trade Name
- Colesterolo Totale EUDAMEDColesterolo Totale - Biotecnica Systems EUDAMED
- Device Name
- Colesterolo Totale/Cholesterol Total EUDAMEDColesterolo Totale/Cholesterol Total - Biotecnica Systems EUDAMED
- Model / Reference
- 0045 EUDAMED0035 EUDAMEDBT0035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172970314 EUDAMED08053172970307 EUDAMED08053172972677 EUDAMED
- Basic UDI-DI
- B-08053172970314 EUDAMEDB-08053172970307 EUDAMEDB-08053172972677 EUDAMED
- EMDN Code
- W01010205 CHOLESTEROL 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
Category: Total cholesterol lipid IVD, reagent
Colesterolo Totale by Giesse Diagnostics Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08053172970314 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED 01822700-0a90-473d-878a-4bddc7cb3b10 61 fields · synced Oct 1, 2026
- EUDAMED 651d73df-dc8f-4e99-beab-2614a86463b2 61 fields · synced May 17, 2026
- EUDAMED 9036c596-f21c-412c-a6b4-d8d03eced191 61 fields · synced May 18, 2026