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Electrical stimulator
EUDAMEDClass IIa (EU MDR)
Ref FDES114Ref FDES112Ref FDES122Ref FDES106
Identity
- Trade Name
- Electrical stimulator EUDAMED
- Device Name
- Electrical stimulator EUDAMED
- Model / Reference
- FDES114 EUDAMEDFDES112 EUDAMEDFDES122 EUDAMEDFDES106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970389634148 EUDAMED06970389634124 EUDAMED06970389634223 EUDAMED06970389634063 EUDAMED
- Basic UDI-DI
- 697038963FDESD1N4 EUDAMED697038963FDESD3N8 EUDAMED
- Direct Marketing DI
- 06970389634148 EUDAMED06970389634124 EUDAMED06970389634223 EUDAMED06970389634063 EUDAMED
- EMDN Code
- N010103 BIPOLAR NERVOUS ELECTROSTIMULATORS, BATTERY-POWERED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMEDNorthern Ireland 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 (4)
- EUDAMED 81170f10-ec14-4065-ac8c-8ffff3456208 61 fields · synced Jul 21, 2026
- EUDAMED 2ae6ccee-e739-4fe5-83cf-a385a71a9386 61 fields · synced May 17, 2026
- EUDAMED dfed6af9-78ff-4748-93b4-3ca48fb103d4 61 fields · synced May 19, 2026
- EUDAMED d33482c8-bfe4-41e3-8de8-ffd8e0b13b5f 61 fields · synced May 19, 2026