Gelfree Net Electrode Cap
by Wuhan Greentek Pty Ltd. 42 variants
Ref GNC-3128Model GNC-1128, GNC-2128, GNC-3128, GNC-1064, GNC-2064, GNC-3064, GNC-4064, GNC-5064, GNC-1032, GNC-2032, GNC-3032, GNC-4032, GNC-5032, GNC-6032, GNC-7032, GNC-1020, GNC-2020, GNC-3020, GNC-4020, GNC-5020, GNC-6020, GNC-7020, GNC-8020, GNC-9020
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 | Number697029534GNCRJ 06970295341802 | Date20 May 2025 | 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- Withdrawn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
- Gelfree Net Electrode Cap
- Model / Reference
- GNC-1128, GNC-2128, GNC-3128, GNC-1064, GNC-2064, GNC-3064, GNC-4064, GNC-5064, GNC-1032, GNC-2032, GNC-3032, GNC-4032, GNC-5032, GNC-6032, GNC-7032, GNC-1020, GNC-2020, GNC-3020, GNC-4020, GNC-5020, GNC-6020, GNC-7020, GNC-8020, GNC-9020
- Primary DI / UDI-DI
- 06970295341802
- Basic UDI-DI
- 697029534GNCRJ
- EMDN Code
- N01010202 EEG extracranic electrodes
- Device Class
- Class I
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000010400
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from Wuhan Greentek Pty 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