Nucleic Acid Extraction Reagent
by Yaneng BIOscience (Shenzhen) Co., Ltd. 12 variants
Ref 200401Model Pathogen DNA (Spin-Column)
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 | Number695593130020040001GL | Date2 Apr 2026 | 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- Withdrawn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
- Pathogen DNA (Spin-Column), 200401
- Primary DI / UDI-DI
- 06955931304793, 06955931304809
- Basic UDI-DI
- 695593130020040001GL
- Direct Marketing DI
- 0695593130479306955931304809
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000013666
- Authorised representative
- Obelis s.a. BE-AR-000000106
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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