Nucleic Acid Purification System
by Hangzhou MiYin Biotechnology Co., Ltd
Ref AUTO-MAGec 32
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 | Number697533032MYNAPSSY 06975330320026 | Date13 May 2024 | 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- Withdrawn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
- Device Name
- Nucleic Acid Purification System
- Model / Reference
- AUTO-MAGec 32
- Primary DI / UDI-DI
- 06975330320026
- Basic UDI-DI
- 697533032MYNAPSSY
- EMDN Code
- W02050106 DNA genomic preparation devices
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041649
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hangzhou MiYin Biotechnology Co., Ltd
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No