Keewell
by Keewell Medical Technology Co., Ltd EUDAMED
Active
Ref FT70Model QW618, FT2800, FT2811, FT2855, FT1800, FT800, FT70
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69542183QH004MF | Date19 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Blood and Infusion Warmers
- Model / Reference
- QW618, FT2800, FT2811, FT2855, FT1800, FT800, FT70
- Primary DI / UDI-DI
- 06954218301210
- Basic UDI-DI
- 69542183QH004MF
- EMDN Code
- Z12040208 Body thermoregulation equipment
- Device Class
- Class IIb
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000016265
- Authorised representative
- Wellita International BV BE-AR-000010384
Other devices from Keewell Medical Technology Co., Ltd
Properties
Show properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No