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Neutrophilic Leukocyte Alkaline Phosphatase Stain (NAP)

EUDAMED

Class A (EU MDR)

Ref 5 Tests

by Baso Diagnostics Inc. Zhuhai

Identity

Trade Name
Neutrophilic Leukocyte Alkaline Phosphatase Stain (NAP) EUDAMED
Device Name
Neutrophilic Leukocyte Alkaline Phosphatase Stain (NAP) EUDAMED
Model / Reference
5 Tests EUDAMED

Identifiers

Primary DI / UDI-DI
06952383301387 EUDAMED
Basic UDI-DI
695238330029GZ EUDAMED
Direct Marketing DI
06952383301387 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

Neutrophilic Leukocyte Alkaline Phosphatase Stain (NAP) 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 (1)

  • EUDAMED 265cd80d-fd06-4d43-8c81-bc813981b291 61 fields · synced Jul 22, 2026