UpnMed
by Shenzhen UpnMed Equipment co., ltd 2 variants
Ref U301-13SAModel U101-3A3SA、U101-3A5SA、U101-3A7SA、U101-3A10SA、U102-1110SA、U103-113SA、U104- 115SA、U142-1110SA、U145-12A7A、U165-13SA、U172-1110SA、U1108-117SA、U1108-1110SA、etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697040488EC0018Q 06970404885982 | Date14 Jun 2024 | StatusActive |
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- Withdrawn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/MDR Active
Specification
- Device Name
- ECG Cable
- Model / Reference
- U101-3A3SA、U101-3A5SA、U101-3A7SA、U101-3A10SA、U102-1110SA、U103-113SA、U104- 115SA、U142-1110SA、U145-12A7A、U165-13SA、U172-1110SA、U1108-117SA、U1108-1110SA、etc, U301-13SA
- Primary DI / UDI-DI
- 06970404885982
- Basic UDI-DI
- 697040488EC0018Q
- EMDN Code
- K02010203 Electrosurgery connection cables, single-use
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000019212
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen UpnMed Equipment co., ltd
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