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C-REACTIVE PROTEIN-hs (CRP-hs)
EUDAMEDClass IVD General (EU MDR)
Ref 31927Ref 23927
Identity
- Device Name
- C-REACTIVE PROTEIN-hs (CRP-hs) EUDAMED
- Model / Reference
- 31927 EUDAMED23927 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287119275 EUDAMED08435287102369 EUDAMED
- Basic UDI-DI
- B-08435287119275 EUDAMEDB-08435287102369 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
New Device
No
EUDAMED
C-REACTIVE PROTEIN-hs (CRP-hs) by Biosystems 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-08435287119275 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 4532768c-56de-4eb1-8370-76e591bede64 61 fields · synced Jul 29, 2026
- EUDAMED 4c6fc4e2-6a1a-4724-bcf2-fbff44707741 61 fields · synced May 17, 2026