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CRP XL Calibrator kit
EUDAMEDClass IVD General (EU MDR)
Ref CPREK-000Ref CPREK-005Ref CPREK-000/IDS
by Diagam S.A.
Identity
- Trade Name
- CRP XL Calibrator kit EUDAMED
- Device Name
- CRP XL Calibrator kit EUDAMED
- Model / Reference
- CPREK-000 EUDAMEDCPREK-005 EUDAMEDCPREK-000/IDS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168004022 EUDAMED05415168007634 EUDAMED05415168017381 EUDAMED
- Basic UDI-DI
- B-05415168004022 EUDAMEDB-05415168007634 EUDAMEDB-05415168017381 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
CRP XL Calibrator 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-05415168004022 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (3)
- EUDAMED 17be22e7-43bc-4bf0-852f-a67190a9718f 61 fields · synced Jul 30, 2026
- EUDAMED edf39fa7-3413-40d8-a855-8989a800af75 61 fields · synced May 17, 2026
- EUDAMED 50af5a22-a67e-4b9b-913e-d1f0f286360c 61 fields · synced May 18, 2026