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Methylene blue solution
EUDAMEDClass A (EU MDR)
Ref 6×500mlRef 4×250mlRef 6×500mLRef 4×250mLRef 4×1000mL
Identity
- Trade Name
- Methylene blue solution EUDAMED
- Device Name
- Acid Fast Stain (Ziehl-Neelsen) EUDAMEDAcid Fast Stain (Kinyoun) EUDAMEDAcid Fast Stain (Ziehl-Neelsen)(For Auto Stainer) EUDAMED
- Model / Reference
- 6×500ml EUDAMED4×250ml EUDAMED4×1000mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952383300991 EUDAMED06952383301028 EUDAMED06952383302520 EUDAMED06952383300694 EUDAMED06952383303824 EUDAMED
- Basic UDI-DI
- 695238330001GB EUDAMED695238330008GR EUDAMED695238330009GT EUDAMED
- Direct Marketing DI
- 06952383300991 EUDAMED06952383301028 EUDAMED06952383302520 EUDAMED06952383303824 EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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 Diagnostics Inc. Zhuhai — 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 | 695238330001GB | Class A | Active |
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Manufacturer
- Manufacturer
- Baso Diagnostics Inc. Zhuhai
- EUDAMED SRN
- CN-MF-000050424
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (7)
- EUDAMED 0fed8f50-41b3-4cbe-8def-303419159fa1 61 fields · synced Aug 2, 2026
- EUDAMED 41d6fdc6-0520-4cd5-9410-65417fed4d23 61 fields · synced May 18, 2026
- EUDAMED 3fdb9c97-0ca9-40c8-9439-894826d0cc2a 61 fields · synced Jun 20, 2026
- EUDAMED d37fa7a7-912c-4c42-bdaf-4f4882776f62 61 fields · synced Jul 10, 2026
- EUDAMED 585ad44c-c562-449e-871f-a3f382109641 61 fields · synced Jul 16, 2026
- EUDAMED 9eba0034-cb98-41a1-88be-096c18a986f1 61 fields · synced Jul 23, 2026
- EUDAMED 50600963-c7d6-4a99-9d89-0440aa1237d0 61 fields · synced Aug 2, 2026