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Complement Component C4
EUDAMEDClass IVD General (EU MDR)
Ref 31085Ref 13085Ref 31074
Identity
- Device Name
- COMPLEMENT COMPONENT C4 EUDAMED
- Model / Reference
- 31085 EUDAMED13085 EUDAMED31074 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287110852 EUDAMED08435287130850 EUDAMED08435287110746 EUDAMED
- Basic UDI-DI
- B-08435287110852 EUDAMEDB-08435287130850 EUDAMEDB-08435287110746 EUDAMED
- EMDN Code
- W0102010205 COMPLEMENT COMPONENT C4 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Complement Component C4 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-08435287110852 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (3)
- EUDAMED 92b01de9-1455-4e52-bf1e-09b2c66928a6 61 fields · synced Jul 20, 2026
- EUDAMED 7c38b6fd-9e66-4ce5-9f46-fab5b1c82354 61 fields · synced May 17, 2026
- EUDAMED 7198ba1e-1bd8-43e7-8efb-b4e94aff3492 61 fields · synced May 18, 2026