Identity
- Trade Name
- Belifu FDA UDI
- Generic Name
- Transcranial electrical stimulation system, pulsed-current FDA UDI
- Device Name
- ZE50100AGT FDA UDI
- Model / Reference
- 50100-10 FDA UDI
- Description
- ZE50100AGT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973602730054 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcranial electrical stimulation system, pulsed-current FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Belifu by Top-Rank Health Care Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Top-Rank Health Care Co., Ltd.
Sources (1)
- FDA UDI 7c1efce1-ffdf-44cc-8e89-e237f279fa5d 34 fields · synced May 30, 2026