Amico Diagnostic Illuminator

Fiber Optic Bent Illuminator, LED, Head Only

Registry build 21.09.26
2manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HJN
Manufacturer City Province Registered as Device types
Vincent Medical(Dongguan)Technology Company Limited Dongguan Guangdong Contract manufacturer 2
Zumax Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 19

Record

Regulatory record for Amico Diagnostic Illuminator
Listed by Amico Diagnostic Incorporated, Canada
FDA product code HJN
Device type Transilluminator, Battery-Powered
Device class Class 1
Regulation 21 CFR 886.1945
Establishment Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2026-02-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Amico Diagnostic Illuminator
Catalogue number Size Status
DH-W35-LL In distribution
DH-W35-BL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welch Allyn, Inc. Welch Allyn, Inc. 9
NeoGlo® Neotech Products, LLC 9
zumax Zumax Medical Co., Ltd. 4
Bernell Bernell 3
Lumindex Dentmate Technology Co., Ltd. 3
NeoGlo Disposable Neotech Products, LLC 2
Venoscope Venoscope, LLC 2
VF1000LED Vein locator Fabinject Industria E Comercio Importacao E Exportacao Ltda 1
EZ-TRI-3600 U.S. Ophthalmic, L.L.C. 1
Astodia Stihler Electronic Gmbh 1
ESU Transilluminator ESU Limited Liability Partnership 1
Wee Sight Transilluminator International Biomedical, Ltd. 1

Showing 12 of 15. All products under Transilluminator, Battery-Powered

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer