Identity
- Trade Name
- CONDUCTIVE GEL EUDAMEDMedvat FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- CONDUCTIVE GEL EUDAMEDFDA UDI
- Model / Reference
- TG-XX EUDAMEDMED-USG-TR-CLEAR-22-2PK-A FDA UDI
- Description
- Conductive Gel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973602730610 EUDAMEDFDA UDI
- Basic UDI-DI
- 697360273CONDUCTIVEGELTC EUDAMED
- 510(k) Number
- K222770 FDA UDI
- FDA Product Code
- GYB FDA UDI
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1275 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Conductive Gel by Top-Rank Health Care Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222770 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697360273CONDUCTIVEGELTC | Class I | Active |
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Manufacturer
- Manufacturer
- TOP-RANK Health Care Co., Ltd.
- EUDAMED SRN
- CN-MF-000014102
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 62158478-0d6a-4a56-86eb-73c4f95584ac 61 fields · synced Oct 5, 2026
- FDA UDI 6bc8ce28-3f67-4f16-a2e8-8ab89e956653 34 fields · synced May 30, 2026
- FDA 510(k) K222770 1 fields · synced May 18, 2026