Identity
- Device Name
- Biochip Reader EUDAMED
- Model / Reference
- SCIARRAY-I EUDAMEDSCIARRAY-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491761263 EUDAMED06975491761249 EUDAMED06975491761256 EUDAMED
- Basic UDI-DI
- B-06975491761263 EUDAMEDB-06975491761249 EUDAMEDB-06975491761256 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Biochip Reader by Shenzhen Sciarray Biotech Co., Ltd. — 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-06975491761263 | 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 6777f54b-03c8-4dfa-880a-4b70a8a483a9 61 fields · synced Jul 12, 2026
- EUDAMED 6829c682-9cfb-446a-ab58-876df8f4b8da 61 fields · synced May 17, 2026
- EUDAMED 0d9b1601-3ca6-4e4b-8566-b0fe710246b6 61 fields · synced May 19, 2026