Identity
- Trade Name
- GEMORE EUDAMED
- Device Name
- Electrodes EUDAMED
- Model / Reference
- FA5050 EUDAMEDFA50100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712832960433 EUDAMED
- Basic UDI-DI
- 471283296electrode6N EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Gemore by Gemore Technology Co., 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 | 471283296electrode6N | Class I | Active |
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Manufacturer
- Manufacturer
- Gemore Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000019446
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED d9441987-5c92-4cf5-9fb8-7e83b769fe62 61 fields · synced May 29, 2026