← Back to catalogue
Alkaline phosphatase (ALP)-Liquizyme (9+1)
EUDAMEDClass B (EU MDR)
Ref 214 005Ref 214 002
Identity
- Trade Name
- Alkaline phosphatase (ALP)-Liquizyme (9+1) EUDAMED
- Device Name
- Alkaline phosphatase (ALP)-Liquizyme (9+1) EUDAMED
- Model / Reference
- 214 005 EUDAMED214 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G45821400584 EUDAMEDG4582140027W EUDAMED
- Basic UDI-DI
- ++G458214MM EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - TOTAL EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 59aa3326-99b5-4bce-ac56-b2cb3916a25d 61 fields · synced Jul 18, 2026
- EUDAMED 66af4e11-9779-40ec-b3f3-4dd121cc30c4 61 fields · synced May 18, 2026
- EUDAMED 7e50add4-7e09-4f88-9ae4-4f00874f7f94 61 fields · synced Jun 19, 2026
- EUDAMED 7b2fd6f8-fe72-4b83-82ff-3e59edc20048 61 fields · synced Jul 18, 2026