Desktop Remote Viewer
Ref KT-0016
Desktop Remote Viewer (KT-0016) is a Class A device made by Hemosonics LLC, registered in EUDAMED on 16 Mar 2026 (Basic UDI-DI 08500037610001CX), active as of 22 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number08500037610001CX 00850003761091 | Date16 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 08500037610001CX
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- Quantra Hemostasis Analyzer
- Model / reference
- KT-0016
- Primary DI / UDI-DI
- 00850003761091
- Basic UDI-DI
- 08500037610001CX
- EMDN code
- W0202029082 Various hemostasis instruments - software accessories
- Device class
- Class A
- EU registration type
- Standard device
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000034476
- Authorised representative
- QbD RepS BV BE-AR-000000040
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