Remi

FDA UDI

Class II (US FDA UDI)

by Epitel, Inc.

Identity

Trade Name: REMI FDA UDI
Generic Name: Electroencephalographic monitoring system FDA UDI
Device Name: REMI Wireless EEG Sensor FDA UDI
Model / Reference: E001-20047 FDA UDI
Description: REMI Wireless EEG Sensor FDA UDI

Identifiers

Primary DI / UDI-DI: 00860005388103 FDA UDI
FDA Product Code: OMC FDA UDI
GXY FDA UDI
GMDN Term: Electroencephalographic monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
882.1320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 1 Inch FDA UDI
Width — 1 Inch FDA UDI
Depth — 0.25 Inch FDA UDI

Category: Electroencephalographic monitoring system

Remi by Epitel, Inc. — 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: Epitel, Inc.

Sources (1)

FDA UDI d35adf76-4d14-4326-8ab4-212186c5cd75 36 fields · synced May 29, 2026