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Auto Stainer for Histology
EUDAMEDClass A (EU MDR)
Ref BSJ-PT104Model BSJ-DB228
Identity
- Trade Name
- Auto Stainer for Histology EUDAMED
- Device Name
- Auto-Stainer EUDAMED
- Model / Reference
- BSJ-DB228 EUDAMEDBSJ-PT104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952383306283 EUDAMED
- Basic UDI-DI
- 695238330006GM EUDAMED
- Direct Marketing DI
- 06952383306283 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 for Histology 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 58c477f3-3fd2-4428-bc1a-6a9a8e686641 61 fields · synced Jun 18, 2026
- EUDAMED 55ac7697-8f95-4e1d-aed3-277fc14ca9fe 61 fields · synced Jun 18, 2026