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ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)
EUDAMEDClass IVD General (EU MDR)
Ref 44547
Identity
- Device Name
- ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2) EUDAMED
- Model / Reference
- 44547 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287144475 EUDAMED
- Basic UDI-DI
- B-08435287144475 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
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
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-08435287144475 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (1)
- EUDAMED d3e4bb70-3ebb-4317-9c2e-e1d9238f137d 61 fields · synced Jun 18, 2026