QA Nucleic Acid Extraction Kit(Magnetic Bead Method)
by Jiangsu Q-Array Co., Ltd. EUDAMED
Active
Ref Q010-50
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69750505924W6 | Date27 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- Q010-50
- Primary DI / UDI-DI
- 06975050592451
- Basic UDI-DI
- 69750505924W6
- Direct Marketing DI
- 06975050592451
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000044646
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Jiangsu Q-Array Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No