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Crp
EUDAMEDClass B (EU MDR)
Ref 1415-0520Ref 1417-0524Ref 1418-0527Ref 1417-0527Ref 1478-0529
Identity
- Trade Name
- CRP EUDAMEDCRP LATEX EUDAMEDCRP LATEX CALIBRATOR EUDAMED
- Device Name
- CRP EUDAMEDCRP LATEX EUDAMED
- Model / Reference
- 1415-0520 EUDAMED1417-0524 EUDAMED1418-0527 EUDAMED1417-0527 EUDAMED1478-0529 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309167616 EUDAMED05204309154951 EUDAMED05204309070930 EUDAMED05204309137084 EUDAMED05204309123407 EUDAMED
- Basic UDI-DI
- 5204309000018NV EUDAMED5204309000019NX EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMEDW0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
Crp 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 | 5204309000018NV | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (5)
- EUDAMED a2cd95ce-81bd-4084-86f6-67e2d8a9b36d 61 fields · synced Jul 31, 2026
- EUDAMED 93b62e52-9f2d-477e-bfbf-d01f88debbc7 61 fields · synced May 17, 2026
- EUDAMED 83ccff22-7ffb-421a-b773-09a7e2f1e427 61 fields · synced May 17, 2026
- EUDAMED 2e1d68ea-5ec6-4deb-93c1-85066b08064c 61 fields · synced May 17, 2026
- EUDAMED 1861c0ea-1604-4e84-af95-25773ac612e4 61 fields · synced May 18, 2026