Identity
- Trade Name
- Ibramed FDA UDI
- Generic Name
- Professional hair-removal electrolysis system FDA UDI
- Device Name
- HF Ibramed is a portable high frequency piece of equipment for facial, body, capillary and podology application. Application frequency is monopolar, that is, only one electrode is used. The function of the gas inside the electrode is to induce the current flow. This gas is excited through the passage of electric current and produces a light, whose color depends on the type of gas used. The gas is then ionized by the high tension, making the glass bulb fluorescent. FDA UDI
- Model / Reference
- HF IBRAMED FDA UDI
- Description
- HF Ibramed is a portable high frequency piece of equipment for facial, body, capillary and podology application. Application frequency is monopolar, that is, only one electrode is used. The function of the gas inside the electrode is to induce the current flow. This gas is excited through the passage of electric current and produces a light, whose color depends on the type of gas used. The gas is then ionized by the high tension, making the glass bulb fluorescent. FDA UDI
Identifiers
- Catalog Number
- 1007011 FDA UDI
- Primary DI / UDI-DI
- 07898961579146 FDA UDI
- FDA Product Code
- KCX FDA UDI
- GMDN Term
- Professional hair-removal electrolysis system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5360 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Professional hair-removal electrolysis system
Ibramed by Ibramed Industria Brasileira de Equipamentos Medicos Eir — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 18f7f028-1749-4441-963a-e1e596c80391 34 fields · synced May 30, 2026