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ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)
EUDAMEDClass IVD General (EU MDR)
Ref 44878Ref 50056Ref 55569Ref 44898Ref 50055
Identity
- Device Name
- ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin) EUDAMED
- Model / Reference
- 44878 EUDAMED50056 EUDAMED55569 EUDAMED44898 EUDAMED50055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287148787 EUDAMED08012992500569 EUDAMED08012992555699 EUDAMED08435287148985 EUDAMED08012992500552 EUDAMED
- Basic UDI-DI
- B-08435287148787 EUDAMEDB-08012992500569 EUDAMEDB-08012992555699 EUDAMEDB-08435287148985 EUDAMEDB-08012992500552 EUDAMED
- EMDN Code
- W0102100499 VASCULITIS - OTHER 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
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
ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin) 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-08435287148787 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (5)
- EUDAMED 19c9a527-d6a8-49a3-b1c7-7b28a778b33e 61 fields · synced Oct 1, 2026
- EUDAMED 0d8abc73-ede6-40f5-b8a6-3b87f699c933 61 fields · synced May 17, 2026
- EUDAMED 48dc1bf6-5c10-421b-92ea-77be84289c19 61 fields · synced May 17, 2026
- EUDAMED 3998f74d-f50d-4e3b-86d1-8327ab147a33 61 fields · synced May 19, 2026
- EUDAMED 0c591fde-f445-465c-9966-67004939a1f5 61 fields · synced May 19, 2026