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Bio Clear
EUDAMEDClass A (EU MDR)
Ref 06-1782QModel Staining kit, solvents and reagents for pathological anatomy
Identity
- Trade Name
- Bio Clear EUDAMED
- Model / Reference
- Staining kit, solvents and reagents for pathological anatomy EUDAMED06-1782Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033976235161 EUDAMED
- Basic UDI-DI
- 080339762W01030799Y5 EUDAMED
- Direct Marketing DI
- 08033976235161 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Bio Clear by Bio-Optica Milano S.p.A. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 080339762W01030799Y5 | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Optica Milano S.p.A.
- EUDAMED SRN
- IT-MF-000027525
Sources (1)
- EUDAMED edd9752b-4d29-448c-b3a8-0c16d71c0aee 61 fields · synced Jun 19, 2026