HIVFIND Whole Blood HIV 1/2 antibody detection self test
by Meril Diagnostics Pvt. Ltd. India EUDAMED
Ref HIVWBS-02Model HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-04
EMDN W0105090302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number2024-IVDR/QS-003/A | Date30 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- 2024-IVDR/QS-003/A Amended
Quality management system EU IVDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 30 Jun 2026
- Expires
- 9 Sep 2028
- Reason
- Mnf data change
- 2024-IVDR/TD-003/A Amended
Technical documentation EU IVDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 30 Jun 2026
- Expires
- 9 Sep 2028
- Reason
- Mnf data change
Specification
- Device Name
- HIVFIND Whole Blood HIV 1/2 antibody detection self test
- Model / Reference
- HIVWBS-01 HIVWBS-02 HIVWBS-03 HIVWBS-04, HIVWBS-02
- Primary DI / UDI-DI
- 08905459004741
- Basic UDI-DI
- 8905459HIVWBSFEL
- Direct Marketing DI
- 08905459004741
- EMDN Code
- W0105090302 HIV 1 / 2 - rt & poc
- Device Class
- Class D
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000028158
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Meril Diagnostics Pvt. Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED c23fa215-ce84-4eab-ae6e-5c8f59d7bcb7