Identity
- Trade Name
- geko EUDAMED
- Device Name
- Neuromuscular Electro-stimulation Device EUDAMED
- Model / Reference
- W-3 EUDAMEDW3FE01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060294771548 EUDAMED
- Basic UDI-DI
- 506029477W3QU EUDAMED
- EMDN Code
- N0199 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
geko by Firstkind Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220327 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 506029477W3QU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Firstkind Limited
- EUDAMED SRN
- GB-MF-000010541
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3eb6a081-17e5-4a82-a8a8-5663b7f81272 85 fields · synced Jun 18, 2026
- FDA 510(k) K220327 1 fields · synced May 18, 2026