Light, Surgical, Ceiling Mounted

Which Manufacturers in China Make This?

2 of the 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Hebei and Jiangxi, and 1 other province.

Beijing Aeonmed Co., Ltd. Hebei, contract manufacturer
Guangdong Kareway Medical Technology Co., Ltd. Guangdong
Nanchang Micare Medical Equipment Co., Ltd. Jiangxi
Shandong Deman Medical Equipment Group Co., Ltd. Shandong
Shenzhen Kaiyan Medical Equipment Co., Ltd. Guangdong, contract manufacturer

How Is FSY Classified?

Light, Surgical, Ceiling Mounted is FDA product code FSY, Class 2, 21 CFR 878.4580.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 453 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (150), Process control (107) and Equipment maintenance (11).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Light, Surgical, Ceiling Mounted

WH Sim.LED ExL

Wall Holder - Sim.LED Examination lights

Light, Surgical, Ceiling Mounted

Sim.LED 500 MC 3p LC

Catalogue number 141-0015636, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 5000 MC 3p LC 160klx

Sim.LED 5000 Multi-Color 3pole low ceiling 160,000 lux

Light, Surgical, Ceiling Mounted

Stellar Surgical Light Series

LED Surgical Light with center focus

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 9p LC Adr. 2

Sim.LED 8000 Single Color 9pole Low Ceiling Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 9p LC Touch Adr. 2

Sim.LED 8000 Single Color 9pole Low Ceiling Touch Address 2

Light, Surgical, Ceiling Mounted

Skytron DoVera

Light, Surgical, consiting of one to three light heads or one to two light heads and monitor arm. One or two light heads may utilize a camera or one light head my utilize a camera with a…

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 9p LC Touch Adr. 2

Sim.LED 8000 Multi Color 9pole Low Ceiling Touch Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 5000 MC 9p HD

Catalogue number 141-0014622, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 9p Adr. 2

Sim.LED 8000 Multi Color 9pole Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 5000 MC 5p LC

Catalogue number 141-0017225, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 3p LC

Sim.LED 8000 Multi Color 3pole Low Ceiling

Light, Surgical, Ceiling Mounted

Sim.LED 7000 SC 3p

Catalogue number 141-0014750, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 500 SC 9p HD LC

Catalogue number 141-0015620, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 5000 MC 9p HD LC

Catalogue number 141-0014623, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 450 MC 3p

Catalogue number 141-0015800, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 9p

Sim.LED 8000 Single Color 9pole

Light, Surgical, Ceiling Mounted

Sim.LED 7000 SC 9p HD LC

Catalogue number 141-0014757, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 5000 MC 3p 160klx

Sim.LED 5000 Multi-Color 3pole 160,000 lux

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 3p

Sim.LED 8000 Multi Color 3pole

Light, Surgical, Ceiling Mounted

Sim.LED 700 SC 9p HD LC

Catalogue number 141-0015630, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 5p LC Adr. 2

Sim.LED 8000 Multi Color 5pole Low Ceiling Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 500 SC 5p LC

2 catalogue numbers from 141-0015618, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 3p LC Touch

Sim.LED 8000 Single Color 3pole Low Ceiling Touch

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 5p Adr. 2

Sim.LED 8000 Single Color 5pole Address 2

Light, Surgical, Ceiling Mounted

Lumos Surgical Light Series

Catalogue number Lumos L5, listed by Skytron, LLC, United States, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 7000 SC 5p

2 catalogue numbers from 141-0017228, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 700 MC 3p LC

Catalogue number 141-0015646, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 3p LC Touch

Sim.LED 8000 Multi Color 3pole Low Ceiling Touch

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 9p LC

Sim.LED 8000 Single Color 9pole Low Ceiling

Light, Surgical, Ceiling Mounted

Sim.LED 4500 3p

Catalogue number 141-0012550, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 3p Touch Adr. 2

Sim.LED 8000 Single Color 3pole Touch Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 7000 SC 9p HD

Catalogue number 141-0014756, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 3p Touch

Sim.LED 8000 Multi Color 3pole Touch

Light, Surgical, Ceiling Mounted

CA S 3p CTØ70

Central Axis Single 3pole for ceiling tube 70mm

Light, Surgical, Ceiling Mounted

Harmony

Ceiling supported surgical lighting system consisting of one or more LED lightheads.

Light, Surgical, Ceiling Mounted

Sim.LED 500 SC 3p LC

Catalogue number 141-0015616, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 5p Touch

Sim.LED 8000 Multi Color 5pole Touch

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 9p LC

Sim.LED 8000 Multi Color 9pole Low Ceiling

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 5p LC

Sim.LED 8000 Multi Color 5pole Low Ceiling

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 3p LC Adr. 2

Sim.LED 8000 Multi Color 3pole Low Ceiling Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 450 MC 9p HD

Catalogue number 141-0015804, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

VidiaPort

VidiaPort Springarm Bottom

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 5p LC Touch Adr. 2

Sim.LED 8000 Multi Color 5pole Low Ceiling Touch Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 5p LC Adr. 2

Sim.LED 8000 Single Color 5pole Low Ceiling Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 700 SC 3p LC

Catalogue number 141-0015626, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 5p Touch

Sim.LED 8000 Single Color 5pole Touch

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 3p LC Adr. 2

Sim.LED 8000 Single Color 3pole Low Ceiling Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 5p LC Touch Adr. 2

Sim.LED 8000 Single Color 5pole Low Ceiling Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 9p Touch

Sim.LED 8000 Single Color 9pole Touch

Light, Surgical, Ceiling Mounted

Sim.LED 5000 SC 9p HD

Catalogue number 141-0014746, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 3p Touch

Sim.LED 8000 Single Color 3pole Touch

Light, Surgical, Ceiling Mounted

Sim.LED 5000 SC 3p

Catalogue number 141-0014740, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 9p Touch Adr. 2

Sim.LED 8000 Multi Color 9pole Touch Address 2

Light, Surgical, Ceiling Mounted

Apex LED

Light Head Apex LED, Burton

Light, Surgical, Ceiling Mounted

Sim.LED 5000 SC 9p LC 160klx

Sim.LED 5000 SC 9pole low ceiling 160,000 lux

Light, Surgical, Ceiling Mounted

Sim.LED 450 SC 9p HD

Catalogue number 141-0015704, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 5000 MC 5p 160klx

Sim.LED 5000 Multi-Color 5pole 160,000 lux

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 3p

Sim.LED 8000 Single Color 3pole

Light, Surgical, Ceiling Mounted

Sim.INTERFACE MC

Catalogue number 191-0013925, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 5000 SC 5p

2 catalogue numbers from 141-0014742, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 MC 3p LC Touch Adr. 2

Sim.LED 8000 Multi Color 3pole Low Ceiling Touch Address 2

Light, Surgical, Ceiling Mounted

Sim.LED 500 MC 5p LC

2 catalogue numbers from 141-0015638, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 700 MC 9p HD LC

Catalogue number 141-0015650, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 700 SC 5p

2 catalogue numbers from 141-0015627, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Advanced Surgical Light Ceiling Mounted LED

Catalogue number SL-500 LED, listed by Advanced Instrumentations, Inc., United States, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

Sim.LED 8000 SC 9p LC Touch

Sim.LED 8000 Single Color 9pole Low Ceiling Touch

Light, Surgical, Ceiling Mounted

Sim.LED 500 SC 5p

2 catalogue numbers from 141-0015617, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

SA Swg 3kg 3p

Spring Arm Swing 3kg 3pole

Light, Surgical, Ceiling Mounted

Sim.LED 3500+ 3p CV wCT wCC

Sim.LED 3500+ 3pole Ceiling Version with ceiling tube and ceiling cover

Light, Surgical, Ceiling Mounted

Sim.LED 700 MC 3p

Catalogue number 141-0015645, listed by S.i.m.e.o.n. Medical GMBH & Co.KG, Germany, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.

Light, Surgical, Ceiling Mounted

YLED-3F (Including Portegra)

LEO - surgical lights (including Portegra)

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