Identity
- Trade Name
- Acid Fast Stain (Auramine O) EUDAMED
- Device Name
- Acid Fast Stain (Auramine O) EUDAMED
- Model / Reference
- 4×250ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952383302094 EUDAMED06952383302100 EUDAMED
- Basic UDI-DI
- 695238330003GF EUDAMED
- Direct Marketing DI
- 06952383302094 EUDAMED06952383302100 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
Acid Fast Stain (Auramine O) 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baso Diagnostics Inc. Zhuhai
- EUDAMED SRN
- CN-MF-000050424
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (4)
- EUDAMED 16991e7b-0e3d-4b7b-9bb5-8adeceb1e303 61 fields · synced Jul 10, 2026
- EUDAMED 72f659ac-6af2-4309-9c6f-c85b05b5c25a 61 fields · synced May 18, 2026
- EUDAMED 5ad88847-6d0f-4945-8b4b-c6635c0aa159 61 fields · synced Jun 18, 2026
- EUDAMED bb86f02e-b9ac-4daa-bd60-09940d0bb619 61 fields · synced Jul 10, 2026