Nico

Replacement Xenon Lamp Module for NICO Myriad-LX, Xenon Light Source, Part Number NN-7064, Model Tx350A

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FSS
Manufacturer City Province Registered as Device types
Shenzhen Kaiyan Medical Equipment Co., Ltd. Shenzhen Guangdong Contract manufacturer 17

Record

Regulatory record for Nico
Listed by Sunoptic Technologies, LLC, United States
FDA product code FSS
Device type Light, Surgical, Floor Standing
Device class Class 2
Regulation 21 CFR 878.4580
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2025-03-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Nico
Catalogue number Size Status
NN-9010 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Maquet Rolite Maquet Gmbh 35
StarTrol Huot Instruments, LLC 9
HarmonyAIR Steris Corporation 6
Aesculap Aesculap AG 5
Lucea LED® Maquet Gmbh 4
Amtai Amtai Medical Equipment, Inc. 4
Nico Myriad-LX Nico Corporation 3
Sunoptic Technologies Sunoptic Technologies, LLC 3
Aurora Surgical Light Series Skytron, LLC 2
Maxx Luxx LED 160 Avante 2
MS Sim.LED OpL wDB S.i.m.e.o.n. Medical GMBH & Co.KG 2
STARLED3 NX Acem SPA 2

Showing 12 of 37. All products under Light, Surgical, Floor Standing

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