Identity
- Trade Name
- BaSO Autostainer ( AS-316MH ) EUDAMED
- Device Name
- Auto Stainer EUDAMED
- Model / Reference
- AS-316MH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889112044 EUDAMED
- Basic UDI-DI
- 471988911AutoStainer5Y EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS 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
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
BaSO Autostainer ( AS-316MH ) by BaSO Biotech Co., LTD.. — 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 | 471988911AutoStainer5Y | Class A | Active |
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Manufacturer
- Manufacturer
- BaSO Biotech Co., LTD..
- EUDAMED SRN
- TW-MF-000018809
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b9bb5d01-1cd5-42f1-b6f7-1c76d5cb3cee 61 fields · synced Jul 11, 2026