Kosmos Tablet G1 + Link (Refurbished)
by EchoNous
Ref R008908
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number93532780KOSMOSWH 09353278001011 | Date29 Oct 2021 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Kosmos
- Model / Reference
- R008908
- Primary DI / UDI-DI
- 09353278001011
- Basic UDI-DI
- 93532780KOSMOSWH
- EMDN Code
- Z11040106 Handheld ultrasound scanners
- Device Class
- Class IIa
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- US-MF-000004161
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from EchoNous
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