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Apolipoprotein A1 & B calibrators kit
EUDAMEDClass IVD General (EU MDR)
Ref ABREK-005Ref ABREK-000
by Diagam S.A.
Identity
- Trade Name
- Apolipoprotein A1 & B calibrators kit EUDAMED
- Device Name
- Apolipoprotein A1 & B calibrators kit EUDAMED
- Model / Reference
- ABREK-005 EUDAMEDABREK-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168007580 EUDAMED05415168004473 EUDAMED
- Basic UDI-DI
- B-05415168007580 EUDAMEDB-05415168004473 EUDAMED
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Apolipoprotein A1 & B calibrators kit 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-05415168007580 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (2)
- EUDAMED 12c49cc2-8758-4368-9fe2-15766cc1b57a 61 fields · synced Jul 15, 2026
- EUDAMED a7bd9e59-08f2-4871-8bc2-f666e2a4086c 61 fields · synced May 18, 2026