iCE Surgical Light

Surgical Light Head With Dual Yoke Assembly - GENE-5P Surgical Light Head With Dual Yoke Assembly - GENE-9P (Camera)

Registry build 21.09.26
5manufacturers in China registered for this device type
599catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Shandong (1), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSY
Manufacturer City Province Registered as Device types
Shenzhen Kaiyan Medical Equipment Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
Beijing Aeonmed Co., Ltd. Sanhe Hebei Contract manufacturer 7
Guangdong Kareway Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 16
Shandong Deman Medical Equipment Group Co., Ltd. Jining Shandong Manufacturer 11
Nanchang Micare Medical Equipment Co., Ltd. Nanchang Jiangxi Manufacturer 8

Record

Regulatory record for iCE Surgical Light
Listed by Amico Clinical Solutions, Canada
FDA product code FSY
Device type Light, Surgical, Ceiling Mounted
Device class Class 2
Regulation 21 CFR 878.4580
Establishment Manufacturer
Record published 2026-04-06
Record revised 2021-01-08 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Label carries manufacturing date, serial number
Storage Handling environment humidity 20 to 90 % RH

Catalogue Numbers

Catalogue numbers for iCE Surgical Light
Catalogue number Size Status
iCE30m In distribution
iCE30m In distribution
iCE30/iCE30 In distribution
iCE30 In distribution
iCE30m In distribution
Roll Stand iCE25 130K Lux In distribution
iCE25/iCE25/iCE25 In distribution
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iCE25/iCE25/iCE25/MH1 In distribution
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iCE25/iCE30/iCE30 In distribution
iCE25/iCE25/iCE25/iCE25 In distribution
iCE30m In distribution
iCE25/iCE25 In distribution
iCE30m In distribution
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iCE25/iCE25 In distribution
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iCE25/MH1/Rad Shield In distribution
iCE30m In distribution
iCE25/iCE25/iCE30/MH1 In distribution
iCE30m In distribution
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iCE30m In distribution
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iCE30m In distribution
iCE25/iCE25/iCE25 In distribution
iCE30m In distribution
iCE30m In distribution
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Single Wall iCE25 In distribution
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LED-130 In distribution
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LED-160 In distribution
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Roll Stand iCE30m 160K Lux In distribution
iCE30m In distribution
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Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HarmonyAIR Steris Corporation 1,344
Volista Maquet Gmbh 677
Powerled TM Maquet Gmbh 287
Devon Cardinal Health 70
Light, Surgical, Ceiling Mounted Maquet Gmbh 68
Alyon Steris Corporation 64
Medical Boom Amico Clinical Solutions 56
Standop Volista® Maquet Gmbh 50
Amtai Amtai Medical Equipment, Inc. 45
Mira Minor Surgery Light Amico Lights Corporation 24
MI Product Line Medical Illumination International, Inc 20
Kenex Kenex (Electro-Medical) Ltd. 18

Showing 12 of 191. All products under Light, Surgical, Ceiling Mounted

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