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Antinuclear Antibodies Spectrum Test Kit (Microarray Chip)
EUDAMEDClass IVD General (EU MDR)
Ref 20T-12
Identity
- Device Name
- Antinuclear Antibodies Spectrum Test Kit (Microarray Chip) EUDAMED
- Model / Reference
- 20T-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491761126 EUDAMED
- Basic UDI-DI
- B-06975491761126 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Antinuclear Antibodies Spectrum Test Kit (Microarray Chip) by Shenzhen Sciarray Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06975491761126 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Sciarray Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000038307
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED caa3eeca-ff12-4ffe-a27c-e7cb5dfcf51b 61 fields · synced Jun 19, 2026