Identity
- Trade Name
- Electrical stimulator EUDAMEDFamidoc FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Electrical stimulator EUDAMED
- Model / Reference
- FDES116 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970389634162 EUDAMEDFDA UDI
- Basic UDI-DI
- 697038963FDESD3N8 EUDAMED
- Direct Marketing DI
- 06970389634162 EUDAMED
- 510(k) Number
- K130723 FDA UDI
- FDA Product Code
- IPF FDA UDIGZJ FDA UDI
- EMDN Code
- N010103 BIPOLAR NERVOUS ELECTROSTIMULATORS, BATTERY-POWERED EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Electrical stimulator by Famidoc Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697038963FDESD3N8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED f3f05acb-2427-4f72-8f6c-04458642f744 61 fields · synced Jun 18, 2026
- FDA UDI 7b0a8333-0e99-4100-973e-954fac3fd84b 33 fields · synced May 30, 2026