Tissue DNA Isolation Kit (Magnetic Bead Method)
by Jiangsu Bioperfectus Technologies Co., Ltd. 3 variants
Ref SDK60109-96T
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697334200SDK60109KU 06973342003418 | Date7 May 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- SDK60109-96T
- Primary DI / UDI-DI
- 06973342003418
- Basic UDI-DI
- 697334200SDK60109KU
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014691
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangsu Bioperfectus Technologies Co., Ltd.
See all devices from Jiangsu Bioperfectus Technologies Co., Ltd. →
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No