Identity
- Trade Name
- Alkaline phosphatase (ALP)-Liquizyme (9+1) EUDAMED
- Device Name
- Alkaline phosphatase (ALP)-Liquizyme (9+1) EUDAMED
- Model / Reference
- 214 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G4582140037Y EUDAMED
- Basic UDI-DI
- ++G458214MM EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - TOTAL EUDAMED
Classification
- Device Class
- Class B 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
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | ++G458214MM | Class B | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 588adfe3-27bf-4a5f-ba45-9087f81fee1e 61 fields · synced Jun 18, 2026