SLHR003E
by Sugentech, Inc. South Korea EUDAMED
Ref SLHR003EModel Surearly SMART Ovulation Hormone Test
EMDN W0102050199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberCR-04-1273-919-26 | Date12 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- CR-04-1273-919-26 Issued
Technical documentation EU IVDR
- Notified body
- Eurofins Electric & Electronics Finland Oy 0537
- Issued
- 12 Aug 2026
- Expires
- 20 Jan 2030
- V74 002704 0025 Withdrawn
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 24 Jan 2025
- Expires
- 20 Jan 2030
- Reason
- Transferred to other nb
Specification
- Model / Reference
- Surearly SMART Ovulation Hormone Test, SLHR003E
- Primary DI / UDI-DI
- 08809408862829
- Basic UDI-DI
- 88094088SLHR-001AC
- EMDN Code
- W0102050199 Fertility function hormones - other
- Device Class
- Class B
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- KR-MF-000023952
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Sugentech, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 00c95205-e93d-4351-b498-bcf37e775015