Nerivio Infinity Refill

FDA UDI

Class II (US FDA UDI)

by Theranica Bio-Electronics, Ltd.

Identity

Trade Name: Nerivio Infinity Refill FDA UDI
Generic Name: Craniofacial analgesia electrical stimulator FDA UDI
Device Name: The Nerivio Infinity Reffil t is a disposable and replaceable unit. It connects to the Nerivio Infinity device by two metal pins located on the inner side of the unit that fit the sockets on the device. The outer side of the unit comes in contact with the skin and transfers the electrical current from the device to the body during the treatment. The refill unit is sufficient for up to 18 treatments of 45 minutes each. The Nerivio Infinity refill unit is equipped with a Near-Field Communication (NFC) chip, to ensure control and authenticity. FDA UDI
Model / Reference: FGD000110 FDA UDI
Description: The Nerivio Infinity Reffil t is a disposable and replaceable unit. It connects to the Nerivio Infinity device by two metal pins located on the inner side of the unit that fit the sockets on the device. The outer side of the unit comes in contact with the skin and transfers the electrical current from the device to the body during the treatment. The refill unit is sufficient for up to 18 treatments of 45 minutes each. The Nerivio Infinity refill unit is equipped with a Near-Field Communication (NFC) chip, to ensure control and authenticity. FDA UDI

Identifiers

Primary DI / UDI-DI: 07290017578200 FDA UDI
FDA Product Code: QGT FDA UDI
GMDN Term: Craniofacial analgesia electrical stimulator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5899 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Craniofacial analgesia electrical stimulator

Nerivio Infinity Refill by Theranica Bio-Electronics, Ltd. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Theranica Bio-Electronics, Ltd.

Sources (1)

FDA UDI 5eb70457-1bfd-4f3f-a3c5-5c192fce7c58 35 fields · synced Jun 6, 2026