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ANTI-nDNA ANTIBODIES (nDNA)
EUDAMEDClass IVD General (EU MDR)
Ref 44825Ref 50064Ref 44817
Identity
- Device Name
- ANTI-nDNA ANTIBODIES (nDNA) EUDAMED
- Model / Reference
- 44825 EUDAMED50064 EUDAMED44817 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287148251 EUDAMED08012992500644 EUDAMED08435287148176 EUDAMED
- Basic UDI-DI
- B-08435287148251 EUDAMEDB-08012992500644 EUDAMEDB-08435287148176 EUDAMED
- EMDN Code
- W0102100105 DS DNA - ANTIBODIES 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
ANTI-nDNA ANTIBODIES (nDNA) 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-08435287148251 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (3)
- EUDAMED 8a05f3de-9f4a-4f94-a6cd-d971731d7ed6 61 fields · synced Aug 1, 2026
- EUDAMED 393fd5d3-960e-483b-a69f-fb95ee5e8fdf 61 fields · synced May 18, 2026
- EUDAMED 48facf8f-346f-49e7-af80-04db7e0b857f 61 fields · synced May 19, 2026