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C-Anca Positive Control
EUDAMEDClass IVD General (EU MDR)
Ref 50368Ref 44912Ref 51866
Identity
- Device Name
- C-ANCA POSITIVE CONTROL EUDAMED
- Model / Reference
- 50368 EUDAMED44912 EUDAMED51866 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08012992503683 EUDAMED08435287108002 EUDAMED08012992518663 EUDAMED
- Basic UDI-DI
- B-08012992503683 EUDAMEDB-08435287108002 EUDAMEDB-08012992518663 EUDAMED
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
New Device
No
EUDAMED
C-Anca Positive Control 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-08012992503683 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (3)
- EUDAMED 5cb22db7-1ebb-4d2c-8a95-8302d19d6c0e 61 fields · synced Jul 26, 2026
- EUDAMED 2ee93052-7d1f-41f4-bec6-86e8b4a84732 61 fields · synced May 18, 2026
- EUDAMED 98a0ee0b-ba21-418e-9f46-ddbe12cf2e25 61 fields · synced May 18, 2026