Patient Cable CP-105T/U
by Fukuda Denshi Co., Ltd. 4 variants
Ref CPR-02BKPDU2033
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 | Number4538612030009U 04538612910630 | Date20 Apr 2023 | 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- Withdrawn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
- Electrocardiographic lead set, reusable
- Model / Reference
- CPR-02BKPDU2033
- Primary DI / UDI-DI
- 04538612910630
- Basic UDI-DI
- 4538612030009U
- EMDN Code
- C020599 Cardiac diagnostic devices - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- JP-MF-000008253
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Fukuda Denshi 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