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Alkaline phosphatase (ALP)-Liquizyme (9+1)

EUDAMED

Class B (EU MDR)

Ref 214 001

by Spectrum for Diagnostic Industries (Joint Stock Company)

Identity

Trade Name: Alkaline phosphatase (ALP)-Liquizyme (9+1) EUDAMED
Device Name: Alkaline phosphatase (ALP)-Liquizyme (9+1) EUDAMED
Model / Reference: 214 001 EUDAMED

Identifiers

Primary DI / UDI-DI: G4582140017U EUDAMED
Basic UDI-DI: ++G458214MM EUDAMED
EMDN Code: W01010105 ALKALINE PHOSPHATASE - TOTAL EUDAMED

Classification

Device Class: Class B EUDAMED
Market of Registration: Germany EUDAMED
France 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

Alkaline phosphatase (ALP)-Liquizyme (9+1) by Spectrum for Diagnostic Industries (Joint Stock Company) — Class B — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
EUDAMED SRN: EG-MF-000033954
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (2)

EUDAMED e4ba530a-3656-47d1-9663-fcc9f0849696 61 fields · synced Jun 19, 2026
EUDAMED b313e6f9-0af5-44b0-a139-49def932bc2f 61 fields · synced Jun 19, 2026