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Formalin concentrate - 10 l
EUDAMEDClass A (EU MDR)
Ref 05-K01010Model Formalin concentrate
Identity
- Trade Name
- Formalin concentrate - 10 l EUDAMED
- Model / Reference
- Formalin concentrate EUDAMED05-K01010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055672950117 EUDAMED
- Basic UDI-DI
- 080556729W010307053D EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) 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
Formalin concentrate - 10 l 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 | 080556729W010307053D | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Optica Milano S.p.A.
- EUDAMED SRN
- IT-MF-000027525
Sources (1)
- EUDAMED d70489b0-1512-4c16-951f-e531970e3530 61 fields · synced Jul 14, 2026