← Back to catalogue
Methylene Blue Solution
EUDAMEDClass A (EU MDR)
Ref TBNX-09CRef TBNX-C10Ref TBX-09C
Identity
- Trade Name
- Methylene Blue Solution EUDAMED
- Device Name
- Microbiology EUDAMED
- Model / Reference
- TBNX-09C EUDAMEDTBNX-C10 EUDAMEDTBX-09C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889110262 EUDAMED04719889110231 EUDAMED04719889110194 EUDAMED
- Basic UDI-DI
- 471988911MicrobiologyZM EUDAMED
- Direct Marketing DI
- 04719889110262 EUDAMED04719889110231 EUDAMED04719889110194 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
Methylene Blue 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 |
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 (3)
- EUDAMED 192c5717-402c-4a6a-9b2e-329f49fefbec 61 fields · synced Aug 2, 2026
- EUDAMED 6b11ed6c-ca45-4533-9948-fbd7d1fa98c6 61 fields · synced May 16, 2026
- EUDAMED eda76983-f3a3-4d1d-8fed-84c207c083b7 61 fields · synced May 18, 2026