Friendship Medical
by Xi'an Friendship Medical Electronics Co., Ltd. 81 variants
Ref 2048Model SEAg-S-500/15X20, SEAg-S
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-16955739020489 16955739020489 | Date21 Feb 2022 | 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- Withdrawn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/MDD Active
Specification
- Device Name
- Disposable Pre-Gelled Surface Electrodes (Ag/AgCl,Single)
- Model / Reference
- SEAg-S-500/15X20, 2048, SEAg-S
- Primary DI / UDI-DI
- 16955739020489
- Basic UDI-DI
- B-16955739020489, 695573902000KY
- Unit of Use DI
- 06955739020482
- 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
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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