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Isopar Ultra
EUDAMEDClass A (EU MDR)
Ref 450008Model Biomarkers, solvents, alcohols and paraffin for histology
Identity
- Trade Name
- Isopar Ultra EUDAMED
- Model / Reference
- Biomarkers, solvents, alcohols and paraffin for histology EUDAMED450008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034120278546 EUDAMED
- Basic UDI-DI
- 080341202W01030799BM EUDAMED
- Direct Marketing DI
- 08034120278546 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
Isopar Ultra 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 | 080341202W01030799BM | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Optica Milano S.p.A.
- EUDAMED SRN
- IT-MF-000027525
Sources (1)
- EUDAMED 0435b8b7-d6d9-43bb-b66e-2386b92b9922 61 fields · synced Jun 19, 2026