BlueLEX

FDA UDI

Class II (US FDA UDI)

by Monitex Industrial Co., Ltd.

Identity

Trade Name: BlueLEX FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: LED Curing Light FDA UDI
Model / Reference: LD-105 FDA UDI
Description: LED Curing Light FDA UDI

Identifiers

Primary DI / UDI-DI: 04711552010015 FDA UDI
FDA Product Code: EBZ FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6070 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Dental/surgical polymerization lamp

BlueLEX by Monitex Industrial Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental/surgical polymerization lamp.

LEDEX — Dentmate Technology Co. , Ltd. · Class II
Flashlite® — Den-Mat Holdings, LLC · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
VALO — ULTRADENT PRODUCTS, INC. · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
VALO — ULTRADENT PRODUCTS, INC. · Class II
Coltolux — Coltene/Whaledent Inc. · Class II
Ascent PX Charging Station — CAO GROUP, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Monitex Industrial Co., Ltd.

Sources (1)

FDA UDI cf926880-11bd-45a8-b6dc-766280101f9d 34 fields · synced May 30, 2026