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Carbolfuchsin solution

EUDAMED

Class A (EU MDR)

Ref 6×500mlRef 4×250mlRef 4×20mLRef 6×500mLRef 4×1000mL

by Baso Diagnostics Inc. Zhuhai

Identity

Trade Name
Carbolfuchsin solution EUDAMED
Device Name
Acid Fast Stain (Ziehl-Neelsen) EUDAMED
Pathological Acid Fast Stain EUDAMED
Acid Fast Stain (Kinyoun) EUDAMED
Acid Fast Stain (Ziehl-Neelsen)(For Auto Stainer) EUDAMED
Model / Reference
6×500ml EUDAMED
4×250ml EUDAMED
4×20mL EUDAMED
4×1000mL EUDAMED

Identifiers

Primary DI / UDI-DI
06952383300182 EUDAMED
06952383301004 EUDAMED
06952383305064 EUDAMED
06952383302506 EUDAMED
06952383303817 EUDAMED
Basic UDI-DI
695238330001GB EUDAMED
695238330022GK EUDAMED
695238330008GR EUDAMED
695238330009GT EUDAMED
Direct Marketing DI
06952383300182 EUDAMED
06952383301004 EUDAMED
06952383302506 EUDAMED
06952383303817 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

Carbolfuchsin 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 bfbba8b1-6c61-4f76-83d1-aac143f0a587 61 fields · synced Jul 17, 2026
  • EUDAMED 3680a6d2-645d-4e40-a0bc-806ab35725f9 61 fields · synced May 18, 2026
  • EUDAMED 3f5f3545-0c8b-4d9b-b44e-8564619b8fe8 61 fields · synced Jun 19, 2026
  • EUDAMED 5f3bc049-494b-40b1-9e8a-c907b82e8475 61 fields · synced Jun 20, 2026
  • EUDAMED 353d2a62-4204-4c6a-b525-e507848aecd4 61 fields · synced Jul 10, 2026
  • EUDAMED 2281ed5f-667b-4d9a-86b4-bdf04ec444b8 61 fields · synced Jul 11, 2026
  • EUDAMED d42b330f-fffb-4218-97a2-2329b41a31c8 61 fields · synced Jul 17, 2026