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Automatic DNA Extraction and Methylation instrument
EUDAMEDClass A (EU MDR)
Ref SEP-8Model SEP-8、SEP-32Ref SEP-32
Identity
- Device Name
- Automatic DNA Extraction and Methylation instrument EUDAMED
- Model / Reference
- SEP-8、SEP-32 EUDAMEDSEP-8 EUDAMEDSEP-32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491760174 EUDAMED06975491760181 EUDAMED
- Basic UDI-DI
- 697549176ADEAMIPM EUDAMED
- EMDN Code
- W02050399 NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - 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 DNA Extraction and Methylation instrument by Shenzhen Sciarray Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697549176ADEAMIPM | 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 bfe671d4-ddae-4a0c-896e-a31ef41040bb 61 fields · synced Sep 18, 2026
- EUDAMED 8d508f76-057a-4e64-8bbd-36be9e1ad3d9 61 fields · synced May 18, 2026