CupiKIT
by Cupid Limited India EUDAMED
Ref CUPHBS-01
EMDN W0105090201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number2026-IVDR/QS-001/A | Date15 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- 2026-IVDR/QS-001/A Amended
Quality management system EU IVDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 15 Oct 2026
- Expires
- 13 Oct 2030
- Reason
- Ar data change
- 2026-IVDR/TD-001/A Amended
Technical documentation EU IVDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 15 Oct 2026
- Expires
- 13 Oct 2030
- Reason
- Ar data change
Specification
- Device Name
- Hepatitis B Surface Antigen (HBsAg) Test Kit
- Model / Reference
- CUPHBS-01
- Primary DI / UDI-DI
- 08906005286024
- Basic UDI-DI
- 890600528cuphbsL5
- Direct Marketing DI
- 08906005286024
- EMDN Code
- W0105090201 Hbsag - rt & poc
- Device Class
- Class D
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- IN-MF-000033199
- Authorised representative
- Amstermed B.V. NL-AR-000001971
Other devices from Cupid Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED a1a439ef-f4af-4ee5-be84-2c3842c7f9da