Identity
- Trade Name
- Counterstain solution EUDAMED
- Device Name
- Acid Fast Stain (Auramine O) EUDAMED
- Model / Reference
- 1000ml EUDAMED4×250ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952383306443 EUDAMED06952383305262 EUDAMED
- Basic UDI-DI
- 695238330003GF EUDAMED
- Direct Marketing DI
- 06952383306443 EUDAMED06952383305262 EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Counterstain solution by Baso Diagnostics Inc. Zhuhai — 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 | 695238330003GF | Class A | Active |
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Manufacturer
- Manufacturer
- Baso Diagnostics Inc. Zhuhai
- EUDAMED SRN
- CN-MF-000050424
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (4)
- EUDAMED 00f979b6-4b0e-4211-9b73-23a4badee02c 61 fields · synced Jul 30, 2026
- EUDAMED 6305cf7f-a150-4120-9461-24ec397d4780 61 fields · synced May 18, 2026
- EUDAMED d43e4500-92ad-4a63-8109-271ffa1786dd 61 fields · synced Jun 19, 2026
- EUDAMED 6177c2b6-65ee-4b37-b6d0-df567896d51d 61 fields · synced Jul 30, 2026