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Alpha1-Acid Glycoprotein
EUDAMEDClass IVD General (EU MDR)
Ref GPTUR-L00
by Diagam S.A.
Identity
- Trade Name
- Alpha1-Acid Glycoprotein EUDAMED
- Device Name
- Alpha1-Acid Glycoprotein EUDAMED
- Model / Reference
- GPTUR-L00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168007979 EUDAMED
- Basic UDI-DI
- B-05415168007979 EUDAMED
- EMDN Code
- W0102019001 A1-ACID GLYCOPROTEIN (OROSOMUCOID) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Alpha1-Acid Glycoprotein by Diagam S.A. — 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-05415168007979 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (1)
- EUDAMED bb09b0ff-9d22-4c03-8857-473636e4926b 61 fields · synced Jun 18, 2026