geko
by Firstkind Limited 12 variants
Ref T3EA02Model T-3
Active
CE MDR
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 | Number506029477T3QK 05060294771258 | Date21 Feb 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Neuromuscular Electro-stimulation Device
- Model / Reference
- T-3, T3EA02
- Primary DI / UDI-DI
- 05060294771258
- Basic UDI-DI
- 506029477T3QK
- EMDN Code
- N0199 Encephalic and peripheral nervous system devices - other
- Device Class
- Class IIa
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- GB-MF-000010541
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Firstkind, 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