Identity
- Trade Name
- Auramine O Solution EUDAMED
- Device Name
- Microbiology EUDAMED
- Model / Reference
- TAX-A10 EUDAMEDTANX-09A EUDAMEDTAX-09A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889110286 EUDAMED04719889110385 EUDAMED04719889110316 EUDAMED
- Basic UDI-DI
- 471988911MicrobiologyZM EUDAMED
- Direct Marketing DI
- 04719889110286 EUDAMED04719889110385 EUDAMED04719889110316 EUDAMED
- EMDN Code
- W0104010804 STAINS 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Auramine O Solution 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 | 471988911MicrobiologyZM | 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 (3)
- EUDAMED 74c30f7a-b194-46ba-9c61-b673e41b3f3c 61 fields · synced Jul 26, 2026
- EUDAMED 43334f11-8a54-4681-aeba-b00fdf0679af 61 fields · synced May 17, 2026
- EUDAMED 7c67c6fb-ebeb-4fd7-a2cf-06c53fcd1ad6 61 fields · synced May 18, 2026