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C-Reactive Protein (crp)
EUDAMEDClass IVD General (EU MDR)
Ref 13921Ref 31921Ref 22921Ref 31321
Identity
- Device Name
- C-REACTIVE PROTEIN (CRP) EUDAMED
- Model / Reference
- 13921 EUDAMED31921 EUDAMED22921 EUDAMED31321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287139211 EUDAMED08435287119213 EUDAMED08435287129212 EUDAMED08435287113211 EUDAMED
- Basic UDI-DI
- B-08435287139211 EUDAMEDB-08435287119213 EUDAMEDB-08435287129212 EUDAMEDB-08435287113211 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 (crp) 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-08435287139211 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (4)
- EUDAMED 43507d6f-b378-4390-80f3-573637cf92ad 61 fields · synced Aug 4, 2026
- EUDAMED 5e968ecd-62ed-4c1c-a490-0f66aa5378cb 61 fields · synced May 17, 2026
- EUDAMED f69cd5ee-fbb0-49da-b7ef-c31192d68388 61 fields · synced May 18, 2026
- EUDAMED a8854bc5-31ec-477c-8e2f-5d566be02d57 61 fields · synced May 18, 2026