1drop for Hospital
by 1drop Inc. South Korea EUDAMED
Ref 400Model 1drop for i-Hospital EMDN W0201069082
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-DSW-I01PLJ | Date31 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- 1drop for i-Hospital, 400
- Primary DI / UDI-DI
- D-DSW-I01PLJ
- Basic UDI-DI
- B-DSW-I01PLJ
- EMDN Code
- W0201069082 Various rapid test chemistry / immunochemistry instruments - software accessories
- Device Class
- Class IVD General
- Special Device Type
- -1202
- 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 (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED D-DSW-I01PLJ|B-DSW-I01PLJ