Ibramed

FDA UDI

Class I (US FDA UDI)

by Ibramed Industria Brasileira de Equipamentos Medicos Eir

Identity

Trade Name: Ibramed FDA UDI
Generic Name: Freestanding electric massager FDA UDI
Device Name: The CRYOTECAR equipment is designed for therapies including Tecartherapy, Radiofrequency, Cryotecartherapy, Cryofrequency, and Fractional techniques. These non-invasive treatments use capacitive and resistive applicators to promote tissue heating, aiding in the temporary improvement of sagging skin, cellulite, and localized fat. Cryotecartherapy and Cryofrequency feature cooled tips for a more comfortable temperature increase. The device supports monopolar and bipolar modes, with capacitive tips for superficial heating and resistive tips for deeper tissue treatment. Fractional Cryofrequency and Radiofrequency create microscopic thermal lesions, enhancing skin tightening in facial and body aesthetics. FDA UDI
Model / Reference: Cryotecar FDA UDI
Description: The CRYOTECAR equipment is designed for therapies including Tecartherapy, Radiofrequency, Cryotecartherapy, Cryofrequency, and Fractional techniques. These non-invasive treatments use capacitive and resistive applicators to promote tissue heating, aiding in the temporary improvement of sagging skin, cellulite, and localized fat. Cryotecartherapy and Cryofrequency feature cooled tips for a more comfortable temperature increase. The device supports monopolar and bipolar modes, with capacitive tips for superficial heating and resistive tips for deeper tissue treatment. Fractional Cryofrequency and Radiofrequency create microscopic thermal lesions, enhancing skin tightening in facial and body aesthetics. FDA UDI

Identifiers

Primary DI / UDI-DI: 07898966442933 FDA UDI
FDA Product Code: IRQ FDA UDI
GMDN Term: Freestanding electric massager FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5950 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Freestanding electric massager

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

Manufacturer: Ibramed Industria Brasileira de Equipamentos Medicos Eir

Sources (1)

FDA UDI 58de5ee1-3a16-4bff-994c-7a6f601df303 33 fields · synced May 30, 2026