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α-Naphthyl Acetate Esterase Stain (α-NAE) (Fast blue method)
EUDAMEDClass A (EU MDR)
Ref 100 Tests (dip staining）
Identity
- Trade Name
- α-Naphthyl Acetate Esterase Stain (α-NAE) (Fast blue method) EUDAMED
- Device Name
- α-Naphthyl Acetate Esterase Stain (α-NAE) (Fast blue method) EUDAMED
- Model / Reference
- 100 Tests (dip staining） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952383301448 EUDAMED
- Basic UDI-DI
- 695238330031GL EUDAMED
- Direct Marketing DI
- 06952383301448 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
α-Naphthyl Acetate Esterase Stain (α-NAE) (Fast blue method) 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 | 695238330031GL | 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 (1)
- EUDAMED c88bf153-73e1-45b0-a8db-78cab90b5277 61 fields · synced Aug 1, 2026