Friendship Medical
by Xi'an Friendship Medical Electronics Co., Ltd. 95 variants
Ref 1085Model NEC3540, NEC
Active
CE MDR CE MDD
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 | NumberB-16955739010855 16955739010855 | Date25 Feb 2022 | StatusActive |
| European Union | CE/MDD | NumberB-16955739010855 16955739010855 | Date25 Feb 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Disposable EMG Concentric Needle Electrodes
- Model / Reference
- NEC3540, 1085, NEC
- Primary DI / UDI-DI
- 16955739010855
- Basic UDI-DI
- B-16955739010855, 695573906001LW
- EMDN Code
- Z121002, Z12100480
- Device Class
- Class IIa
- 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 (12)
- 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