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Alkaline Phosphatase (alp)
EUDAMEDClass B (EU MDR)
Ref 1419-0130Ref 1516-0130Ref 1415-0130Ref 1417-0137
Identity
- Trade Name
- ALKALINE PHOSPHATASE (ALP) EUDAMED
- Device Name
- ALKALINE PHOSPHATASE (ALP) EUDAMED
- Model / Reference
- 1419-0130 EUDAMED1516-0130 EUDAMED1415-0130 EUDAMED1417-0137 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309161188 EUDAMED05204309175321 EUDAMED05204309167319 EUDAMED05204309136827 EUDAMED
- Basic UDI-DI
- 5204309000006NN EUDAMED
- Direct Marketing DI
- 05204309161188 EUDAMED05204309167319 EUDAMED05204309136827 EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - TOTAL EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Greece 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) by Medicon Hellas SA — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5204309000006NN | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (4)
- EUDAMED b804eb02-62e4-4c3d-9f96-014e5607188a 61 fields · synced Jul 29, 2026
- EUDAMED 03704ef8-0b6e-41f8-b352-335fa1fbc2e3 61 fields · synced May 18, 2026
- EUDAMED 81936cb7-7949-412a-a66f-84941851c874 61 fields · synced May 18, 2026
- EUDAMED 7f0a50a5-fe8b-44ba-8cd5-2511407baa3b 61 fields · synced May 18, 2026