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Gelfree-S3 Electrode Cap
EUDAMEDClass I (EU MDR)
Ref S3-1011Model S3-1032, S3-2032, S3-3032, S3-4032, S3-1023, S3-2023, S3-3023, S3-4023, S3-1022, S3-2022, S3-3022, S3-4022, S3-1020, S3-2020, S3-3020, S3-4020, S3-1017, S3-2017, S3-3017, S3-4017, S3-1011, S3-2011, S3-3011, S3-4011, S3-1008, S3-2008, S3-3008, S3-4008
Identity
- Device Name
- Gelfree-S3 Electrode Cap EUDAMED
- Model / Reference
- S3-1032, S3-2032, S3-3032, S3-4032, S3-1023, S3-2023, S3-3023, S3-4023, S3-1022, S3-2022, S3-3022, S3-4022, S3-1020, S3-2020, S3-3020, S3-4020, S3-1017, S3-2017, S3-3017, S3-4017, S3-1011, S3-2011, S3-3011, S3-4011, S3-1008, S3-2008, S3-3008, S3-4008 EUDAMEDS3-1011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970295340898 EUDAMED
- Basic UDI-DI
- 697029534S3ZB EUDAMED
- EMDN Code
- N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Gelfree-S3 Electrode Cap by Wuhan Greentek Pty Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697029534S3ZB | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Greentek Pty Ltd.
- EUDAMED SRN
- CN-MF-000010400
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 8b62c937-4d58-49ea-9f43-ae6560fef0b4 61 fields · synced Jun 18, 2026