Identity
- Trade Name
- Friendship Medical EUDAMEDFDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Disposable Pre-Gelled Surface Electrodes (Ag/AgCl,Single); Disposable Pre-Gelled Surface Electrodes (Ag/AgCl,Ground); Disposable Pre-Gelled Surface Electrodes (Ag/AgCl,Round,Single) EUDAMED
- Model / Reference
- SEAg-S EUDAMED2005 EUDAMEDSEAg-S-2500/20×27 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16955739020052 EUDAMEDFDA UDI
- Basic UDI-DI
- 695573902000KY EUDAMED
- Unit of Use DI
- 06955739020055 EUDAMED
- 510(k) Number
- K110289 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Friendship Medical by Xi'an Friendship Medical Electronics Co., Ltd. — Class I — 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 | 695573902000KY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Xi'an Friendship Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000004202
- Authorised Representative
- Friendship Europe ApS DK-AR-000001593
Sources (2)
- EUDAMED 73983a17-fc83-4192-9f23-c33af605359f 61 fields · synced Jul 17, 2026
- FDA UDI b0e0996e-a11a-4400-ba23-0c6d624658eb 33 fields · synced May 26, 2026