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Methylene blue solution

EUDAMED

Class A (EU MDR)

Ref 6×500mlRef 4×250mlRef 6×500mLRef 4×250mLRef 4×1000mL

by Baso Diagnostics Inc. Zhuhai

Identity

Trade Name
Methylene blue solution EUDAMED
Device Name
Acid Fast Stain (Ziehl-Neelsen) EUDAMED
Acid Fast Stain (Kinyoun) EUDAMED
Acid Fast Stain (Ziehl-Neelsen)(For Auto Stainer) EUDAMED
Model / Reference
6×500ml EUDAMED
4×250ml EUDAMED
4×1000mL EUDAMED

Identifiers

Primary DI / UDI-DI
06952383300991 EUDAMED
06952383301028 EUDAMED
06952383302520 EUDAMED
06952383300694 EUDAMED
06952383303824 EUDAMED
Basic UDI-DI
695238330001GB EUDAMED
695238330008GR EUDAMED
695238330009GT EUDAMED
Direct Marketing DI
06952383300991 EUDAMED
06952383301028 EUDAMED
06952383302520 EUDAMED
06952383303824 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

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Manufacturer

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