Anatolia Geneworks
by Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S. 17 variants
Ref MAG48
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 | Number868001894EXIMGS0480156 08680018940585 | Date11 Jan 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- Withdrawn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
- Magnesia 2448 Nucleic Acid Extraction & PCR Setup Robot
- Model / Reference
- MAG48
- Primary DI / UDI-DI
- 08680018940585
- Basic UDI-DI
- 868001894EXIMGS0480156
- Direct Marketing DI
- 08680018940585
- EMDN Code
- W02050106 DNA genomic preparation devices
- Device Class
- Class A
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000022487
Other devices from Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
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