Friendship Medical
by Xi'an Friendship Medical Electronics Co., Ltd. 81 variants
Ref 1141Model EW-P1; EW-P2; EW-P1/P2
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 | Number695573904001LG 16955739011418 | Date10 Jul 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- Withdrawn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
- Medical Extension Lead Wires
- Model / Reference
- EW-P1, EW-P2, EW-P1/P2, 1141
- Primary DI / UDI-DI
- 16955739011418
- Basic UDI-DI
- 695573904001LG
- Unit of Use DI
- 06955739011411
- EMDN Code
- Z121002 Nervous system monitoring systems
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000004202
- Authorised representative
- Friendship Europe ApS DK-AR-000001593
Other devices from Xi'an Friendship Medical Electronics Co., Ltd.
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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