1drop™ AST
by 1drop Inc. South Korea EUDAMED
Ref O19190Model O19
EMDN W0101060199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-O191902A | Date21 Aug 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- 1drop™ AST Test Cartridges
- Model / Reference
- O19, O19190
- Primary DI / UDI-DI
- D-O191902A
- Basic UDI-DI
- B-O191902A
- EMDN Code
- W0101060199 Blood test strips (cc) - rapid tests and "point of care" - other
- Device Class
- Class IVD General
- Market of Registration
- Greece
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 (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED D-O191902A|B-O191902A