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: Hooke is a microcontrolled, non-ablative, high frequency radiofrequency equipment (27.12MHz), which can be used in the areas of facial and body aesthetics. The equipment has four applicators: three radiofrequency applicators, FACIAL (small bipolar applicator), BIPOLAR (body bipolar applicator) and MONOPOLAR (body monopolar applicator) and a COOLING applicator (air-cooled) for thermal comfort and preservation of the epidermis. FDA UDI
Model / Reference: Hooke FDA UDI
Description: Hooke is a microcontrolled, non-ablative, high frequency radiofrequency equipment (27.12MHz), which can be used in the areas of facial and body aesthetics. The equipment has four applicators: three radiofrequency applicators, FACIAL (small bipolar applicator), BIPOLAR (body bipolar applicator) and MONOPOLAR (body monopolar applicator) and a COOLING applicator (air-cooled) for thermal comfort and preservation of the epidermis. FDA UDI

Identifiers

Primary DI / UDI-DI: 07898966442964 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

FDA UDI

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 3eb41c89-100a-4862-82b9-d8e19ba53eae 33 fields · synced Jun 6, 2026