Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED FDA UDI
Generic Name: Head-worn lamp FDA UDI
Device Name: C3, 3WATT PORTABLE LED HEADLIGHT SYSTEM MOUNTED ON COMFORT FULLY ADJUSTABLE HEADBAND. INCLUDING-HEADLIGHT, RECHARGEABLE LITHIUM BATTERY PACK W/BUILT IN BELT CLIP, BATTERY CHARGER AND CARRYING CASE FDA UDI
Model / Reference: 9700 FDA UDI
Description: C3, 3WATT PORTABLE LED HEADLIGHT SYSTEM MOUNTED ON COMFORT FULLY ADJUSTABLE HEADBAND. INCLUDING-HEADLIGHT, RECHARGEABLE LITHIUM BATTERY PACK W/BUILT IN BELT CLIP, BATTERY CHARGER AND CARRYING CASE FDA UDI

Identifiers

Catalog Number: 9700 FDA UDI
Primary DI / UDI-DI: 00842180183308 FDA UDI
FDA Product Code: HPP FDA UDI
GMDN Term: Head-worn lamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4335 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Head-worn lamp

Elmed by Elmed Incorporated — 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: Elmed Incorporated

Sources (1)

FDA UDI c8d957ee-83b8-4604-975d-5a5ae66060cc 35 fields · synced May 30, 2026