Identity
- Trade Name
- Electrical stimulator EUDAMED
- Device Name
- Electrical stimulator EUDAMED
- Model / Reference
- FDES123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970389634230 EUDAMED
- Basic UDI-DI
- 697038963FDESD1N4 EUDAMED
- Direct Marketing DI
- 06970389634230 EUDAMED
- EMDN Code
- N010103 BIPOLAR NERVOUS ELECTROSTIMULATORS, BATTERY-POWERED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta 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
Electrical stimulator by Famidoc Technology Co., Ltd. — Class IIa — 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 | 697038963FDESD1N4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Famidoc Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016603
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d533cddc-3275-4003-be2e-22f5f816ccaf 61 fields · synced Jun 18, 2026