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ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)
EUDAMEDClass IVD General (EU MDR)
Ref 44509Ref 50060Ref 44108
Identity
- Device Name
- ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) EUDAMED
- Model / Reference
- 44509 EUDAMED50060 EUDAMED44108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287144093 EUDAMED08012992500606 EUDAMED08435287141085 EUDAMED
- Basic UDI-DI
- B-08435287144093 EUDAMEDB-08012992500606 EUDAMEDB-08435287141085 EUDAMED
- EMDN Code
- W0102100101 ANA SCREENING 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
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-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) 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-08435287144093 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (3)
- EUDAMED f0c7bf6b-4b09-4457-a4c1-497f30943fe0 61 fields · synced Oct 6, 2026
- EUDAMED 925822f9-2d9d-4d77-bd54-0a2308657d63 61 fields · synced May 18, 2026
- EUDAMED 363e87ef-5884-44f0-8570-18dd58db491b 61 fields · synced May 18, 2026