← Back to catalogue
10% neutral buffered formalin (ready to use)
EUDAMEDClass A (EU MDR)
Ref 05-01P05Model Fixatives, decalcifiers, formalin prefilled
Identity
- Trade Name
- 10% neutral buffered formalin (ready to use) EUDAMED
- Device Name
- Fixatives, decalcifier, formalin prefilled EUDAMED
- Model / Reference
- Fixatives, decalcifiers, formalin prefilled EUDAMED05-01P05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033976231880 EUDAMED
- Basic UDI-DI
- 080339762W01030705X2 EUDAMED
- Direct Marketing DI
- 08033976231880 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
10% neutral buffered formalin (ready to use) 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 | 080339762W01030705X2 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Optica Milano S.p.A.
- EUDAMED SRN
- IT-MF-000027525
Sources (1)
- EUDAMED b0044211-0a2d-44aa-8c5c-854e2d7d86c0 61 fields · synced Jun 18, 2026