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Fully Automatic Nucleic Acid Extraction and Detection Integrated Machine
EUDAMEDClass A (EU MDR)
Ref BTK-16
Identity
- Device Name
- Fully Automatic Nucleic Acid Extraction and Detection Integrated Machine EUDAMED
- Model / Reference
- BTK-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541564571 EUDAMED
- Basic UDI-DI
- 697454156012KY EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS 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
Fully Automatic Nucleic Acid Extraction and Detection Integrated Machine by Bioteke Corporation (Wuxi) 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 | 697454156012KY | Class A | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2b4f67f2-f226-480d-97d0-59180e14cff8 61 fields · synced Jun 18, 2026