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

EUDAMED

Class B (EU MDR)

Ref 214 004

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: 214 004 EUDAMED

Identifiers

Primary DI / UDI-DI: G45821400482 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 2e0c445a-0009-48b4-a387-d57753f60103 61 fields · synced Jun 18, 2026
EUDAMED 5832f530-f4b9-403a-b2db-cb2fd7a04ce9 61 fields · synced Jun 18, 2026