Vitamin D Home Test
by Azubio Diagnostics Co., Ltd EUDAMED
Active
Ref A70410H31
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6188356CE02 | Date6 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- 6188356CE02 Supplemented
Quality management system EU IVDR
- Notified body
- Notified body 0344
- Issued
- 6 Aug 2026
- Expires
- 1 Jan 2031
- Reason
- Add device or group
- 6188356TD01 Amended
Technical documentation EU IVDR
- Notified body
- Notified body 0344
- Issued
- 9 Feb 2026
- Expires
- 1 Jan 2031
- Reason
- Mnf data change
Specification
- Model / Reference
- A70410H31
- Primary DI / UDI-DI
- 16979452730098
- Basic UDI-DI
- 697945273A70410H9G
- EMDN Code
- W0102060309 25-hydroxyvitamin d
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000032581
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Azubio Diagnostics Co., Ltd
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No