Viral Nucleic Acid Extraction Kit (Spin Column)
by Healgen Scientific Limited Liability Company EUDAMED
Active
Ref SNCE07-AHG50E
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-81649002SNCE07KZV4 | Date26 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Viral Nucleic Acid Extraction Kit (Spin Column)
- Model / Reference
- SNCE07-AHG50E
- Primary DI / UDI-DI
- D-81649002SNCE07KZV4
- Basic UDI-DI
- B-81649002SNCE07KZV4
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000018839
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Healgen Scientific Limited Liability Company
See all devices from Healgen Scientific Limited Liability Company →
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No