One Step LH Urine
by Atlas Link Technology Co., Ltd. EUDAMED
Active
Ref C1106.01
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIVDR 783878 | Date3 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IVDR 783878 Supplemented
Technical documentation EU IVDR
- Notified body
- Notified body 2797
- Issued
- 3 Jul 2026
- Expires
- 26 Apr 2031
- Reason
- Add device or group
Specification
- Device Name
- One Step LH Urine Test
- Model / Reference
- C1106.01
- Primary DI / UDI-DI
- 06970725813633
- Basic UDI-DI
- 697072581B1LTH00N30S11CEG
- EMDN Code
- W0102160304 Lh - rt & poc
- Device Class
- Class B
- 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 (10)
- 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
- New Device: No