Identity
- Trade Name
- Fosfatasi Alcalina (DGKC) EUDAMED
- Device Name
- Fosfatasi Alcalina (DGKC)/ Alkaline Phosphatase (DGKC) EUDAMEDFosfatasi Alcalina (DGKC)/Alkaline Phosphatase (DGKC) - Biotecnica Systems EUDAMED
- Model / Reference
- 4097 EUDAMEDBT4096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172970048 EUDAMED08053172972868 EUDAMED
- Basic UDI-DI
- B-08053172970048 EUDAMEDB-08053172972868 EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Fosfatasi Alcalina (DGKC) by Giesse Diagnostics Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08053172970048 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (2)
- EUDAMED c870592f-d9a2-4a74-bcec-81fe0d9ca857 61 fields · synced Jul 11, 2026
- EUDAMED bc22527c-ecae-4aac-839f-ed3cc969f38f 61 fields · synced May 18, 2026