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Automatic Nucleic Acid Extraction and Purification Instrument
EUDAMEDClass A (EU MDR)
Ref SET-96Model SET-48、SET-96Ref SET-48
Identity
- Device Name
- Automatic Nucleic Acid Extraction and Purification Instrument EUDAMED
- Model / Reference
- SET-48、SET-96 EUDAMEDSET-96 EUDAMEDSET-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491760167 EUDAMED06975491760150 EUDAMED
- Basic UDI-DI
- 697549176ANAEAPIYC EUDAMED
- EMDN Code
- W02050299 MICRO-ARRAY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Automatic Nucleic Acid Extraction and Purification Instrument by Shenzhen Sciarray Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697549176ANAEAPIYC | Class A | 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 (2)
- EUDAMED 712b6378-39a0-46ae-ab17-1477df8d69b2 61 fields · synced Jul 27, 2026
- EUDAMED 6be1e5e6-2d11-44aa-8571-4f2349dcf11e 61 fields · synced May 18, 2026