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BaSO Autostainer ( AS-316T )
EUDAMEDClass A (EU MDR)
Ref AS-316TRef BaSO Autostainer
Identity
- Trade Name
- BaSO Autostainer ( AS-316T ) EUDAMED
- Device Name
- Auto Stainer EUDAMED
- Model / Reference
- AS-316T EUDAMEDBaSO Autostainer EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889112075 EUDAMED04719889112006 EUDAMED
- Basic UDI-DI
- 471988911AutoStainer5Y EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMEDW020304 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
Category: Microscope slide stainer IVD
BaSO Autostainer ( AS-316T ) 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 (2)
- EUDAMED fb41b2d6-6ad0-4eca-b5bb-a9d3a3839f93 61 fields · synced Jul 22, 2026
- EUDAMED cbab084c-9dfe-4bd2-9bc1-43b900825295 61 fields · synced May 17, 2026