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Antinuclear Antibodies Spectrum Test Kit (Microarray Chip)
EUDAMEDClass IVD General (EU MDR)
Ref 20-5 tests/ kitRef 20T-5Ref 20-12 tests/ kit
Identity
- Device Name
- Antinuclear Antibodies Spectrum Test Kit (Microarray Chip) EUDAMED
- Model / Reference
- 20-5 tests/ kit EUDAMED20T-5 EUDAMED20-12 tests/ kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491761157 EUDAMED06975491761133 EUDAMED06975491761140 EUDAMED
- Basic UDI-DI
- B-06975491761157 EUDAMEDB-06975491761133 EUDAMEDB-06975491761140 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-06975491761157 | 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 (3)
- EUDAMED ed62e165-358c-4579-b9f3-3adec067190a 61 fields · synced Jul 24, 2026
- EUDAMED 92d8c1af-2d30-4966-aa67-f266085c9636 61 fields · synced May 17, 2026
- EUDAMED 916d73f7-65eb-495b-8f91-2955ea3fb976 61 fields · synced May 18, 2026