EzeeFind™ Early Pregnancy Test
by Meril Diagnostics Pvt. Ltd. India EUDAMED
Ref EZFRPD-03 Model EZFRPD-01 EZFRPD-02 EZFRPD-03 EZFRPD-04
EMDN W0102050105
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number8905459HCGRTSF8Q | Date2 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- 2024-IVDR/QS-009/A Amended
Quality management system EU IVDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 30 Jun 2026
- Expires
- 11 Nov 2029
- Reason
- Mnf data change
- 2024-IVDR/TD-009 Amended
Technical documentation EU IVDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 30 Jun 2026
- Expires
- 11 Nov 2029
- Reason
- Mnf data change
Specification
- Device Name
- EzeeFind™ Early Pregnancy Test
- Model / Reference
- EZFRPD-01 EZFRPD-02 EZFRPD-03 EZFRPD-04, EZFRPD-03
- Primary DI / UDI-DI
- 08905459006707
- Basic UDI-DI
- 8905459HCGRTSF8Q
- Direct Marketing DI
- 08905459006707
- EMDN Code
- W0102050105 Luteinising hormone
- Device Class
- Class B
- 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 0136f503-4aff-4e2a-8169-49ffc415aa57