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Sudan Black
EUDAMEDClass A (EU MDR)
Ref 05-B27202Model Staining solution for tissue sections
Identity
- Trade Name
- Sudan Black EUDAMED
- Device Name
- Staining solution for tissue sections EUDAMED
- Model / Reference
- Staining solution for tissue sections EUDAMED05-B27202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033976233815 EUDAMED
- Basic UDI-DI
- 080339762W01030708X8 EUDAMED
- Direct Marketing DI
- 08033976233815 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (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
Sudan Black 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 | 080339762W01030708X8 | Class A | Active |
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Manufacturer
- Manufacturer
- Bio-Optica Milano S.p.A.
- EUDAMED SRN
- IT-MF-000027525
Sources (1)
- EUDAMED 75fbd3b5-f54c-46a5-910f-9ea7d8410755 61 fields · synced Jun 19, 2026