Respiratory Antigen Multiple Test Kit
by Atlas Link Technology Co., Ltd. EUDAMED
Active
Ref C2134-RF-03Model C2134
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIVDR 829096 | Date25 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IVDR 829096 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 2797
- Issued
- 25 Jun 2026
- Expires
- 24 Jun 2031
Specification
- Device Name
- Respiratory Antigen Multiple Test Kit
- Model / Reference
- C2134, C2134-RF-03
- Primary DI / UDI-DI
- 06970725815484
- Basic UDI-DI
- 697072581D2SRF25M32P15CT3
- EMDN Code
- W0105070503 Respiratory tract infections - multiplex na reagents
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000021058
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Atlas Link Technology Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No