TENS & EMS Device
by Dongguan Goceng Medical Supplies Co., Ltd 12 variants
Ref GC-TE025Model GC-TE019、GC-TE020、GC-TE021、GC-TE022、GC-TE023、GC-TE024、GC-TE025、GC-TE026、GC-TE027、GC-TE028、GC-TE029、GC-TE030 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 | Number697756344GCTES8 06977563442063 | Date18 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- Withdrawn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
- TENS & EMS Device
- Model / Reference
- GC-TE019、GC-TE020、GC-TE021、GC-TE022、GC-TE023、GC-TE024、GC-TE025、GC-TE026、GC-TE027、GC-TE028、GC-TE029、GC-TE030 etc, GC-TE025
- Primary DI / UDI-DI
- 06977563442063
- Basic UDI-DI
- 697756344GCTES8
- EMDN Code
- Z120602 Physiotherapy equipment
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042512
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Dongguan Goceng Medical Supplies Co., Ltd
See all devices from Dongguan Goceng Medical Supplies 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