Light, Surgical, Instrument

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Shandong and Zhejiang: 6 hold an FDA registration. 1 is a contract manufacturer.

Dongguan Kaiser Technology Co., Ltd. Guangdong, contract manufacturer
Qufu Lekang Medical Technology Group Co., Ltd. Shandong
Shandong Chenhong Medical Technology Co., Ltd. Shandong
Shenzhen Yinghuada Technology Co., Ltd. Guangdong
Shenzhen Shanglaite Electronic Technology Co., Ltd. Guangdong
Zhejiang Fude Medphotonic Co., Ltd. Zhejiang

What Is FDA Product Code FSQ?

Light, Surgical, Instrument is FDA product code FSQ, 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.

Light, Surgical, Instrument

Rutilight Power Supply

Catalogue number FA-RL01, listed by Swan Medical SL, Spain, under Light, Surgical, Instrument. 6 manufacturers in China are registered for this product code.

Light, Surgical, Instrument

Rutiside

Catalogue number RS-01, listed by Swan Medical SL, Spain, under Light, Surgical, Instrument. 6 manufacturers in China are registered for this product code.

Light, Surgical, Instrument

iLED

3 catalogue numbers from 4028310, listed by Baxter Medical Systems GmbH + Co. KG, Germany, under Light, Surgical, Instrument. 6 manufacturers in China are registered for this product code.

Light, Surgical, Instrument

Neo Surgical Lights

Neo Flex Light - 200 mm

Light, Surgical, Instrument

iLED7 Surgical Light

iLED 7 Ceiling Duo

Light, Surgical, Instrument

TL 5000/3000 – Surgical Light

TruLight 5000 / 3000 Ceiling Quad

Light, Surgical, Instrument

Sterilizable Handles

Sterilizable Central Handle, 1 pc

Light, Surgical, Instrument

Rutilight

Catalogue number RL-01, listed by Swan Medical SL, Spain, under Light, Surgical, Instrument. 6 manufacturers in China are registered for this product code.

Light, Surgical, Instrument

TruLight

Hillrom™ TruLight 5000 / 3000 Ceiling Duo

Light, Surgical, Instrument

Spotlight

SPOTLIGHT PL LIGHTED BLADE RIGHT 80mm

Light, Surgical, Instrument

Who Makes This Device Type in China?

What Is FDA Product Code FSQ?

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

Where China Actually Supplies