Identity
- Trade Name
- Auto Stainer EUDAMED
- Device Name
- Auto-Stainer EUDAMED
- Model / Reference
- BSJ-DB228 EUDAMEDBSZ-TS116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952383305736 EUDAMED
- Basic UDI-DI
- 695238330006GM EUDAMED
- Direct Marketing DI
- 06952383305736 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Microscope slide stainer IVD
Auto Stainer by Baso Diagnostics Inc. Zhuhai — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 695238330006GM | 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 (2)
- EUDAMED 0284f51b-963e-4840-b6c1-9365128e0d19 61 fields · synced Jun 19, 2026
- EUDAMED 63861271-6680-4bfb-ab60-d0a7e961d89a 61 fields · synced Jun 19, 2026