Esu Transilluminator

FDA UDI

Class I (US FDA UDI)

by Esu Limited Liability Partnership

Identity

Trade Name: ESU TRANSILLUMINATOR FDA UDI
Generic Name: Infrared-light vein locator FDA UDI
Device Name: The device supports the identification of veins in neonates and infants for venipuncture through the use of an LED that emits a wavelength close to the "optical window," allowing for deeper light penetration into human tissue. FDA UDI
Model / Reference: MK-02GX FDA UDI
Description: The device supports the identification of veins in neonates and infants for venipuncture through the use of an LED that emits a wavelength close to the "optical window," allowing for deeper light penetration into human tissue. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860003720509 FDA UDI
FDA Product Code: HJN FDA UDI
GMDN Term: Infrared-light vein locator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1945 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

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

Category: Infrared-light vein locator

Esu Transilluminator by Esu Limited Liability Partnership — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared-light vein locator.

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Wee Sight Transilluminator — INTERNATIONAL BIOMEDICAL, LTD. · Class I
Vein Illuminator — MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. · Class I
AHT INC — AHT INC · Class I
Vein Illuminator — MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. · Class I

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: Esu Limited Liability Partnership

Sources (1)

FDA UDI 4b95d23f-716d-4e61-8527-6e06a703adf1 33 fields · synced May 30, 2026