1drop™ Hemo
by 1drop Inc. South Korea EUDAMED
Ref H18190Model H18
EMDN W0101060199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-H1890PM | Date31 Jul 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- 1drop™ Hemo Hemoglobin Test Cartridges
- Model / Reference
- H18, H18190
- Primary DI / UDI-DI
- D-H1890PM
- Basic UDI-DI
- B-H1890PM
- EMDN Code
- W0101060199 Blood test strips (cc) - rapid tests and "point of care" - other
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000026103
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from 1drop Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED D-H1890PM|B-H1890PM