Identity
- Trade Name
- BaSO Autostainer ( AS-316GH ) EUDAMED
- Device Name
- Auto Stainer EUDAMED
- Model / Reference
- AS-316GH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889112020 EUDAMED
- Basic UDI-DI
- 471988911AutoStainer5Y EUDAMED
- EMDN Code
- W020304 MICROBIOLOGY GRAM STAINER 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
BaSO Autostainer ( AS-316GH ) by BaSO Biotech Co., LTD.. — 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 | 471988911AutoStainer5Y | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BaSO Biotech Co., LTD..
- EUDAMED SRN
- TW-MF-000018809
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 46f2f8c8-6ad6-41b8-ad60-ff95bfafd81b 61 fields · synced Jul 20, 2026