Everlux PRO

4 catalogue numbers from R00, listed by Ecleris SRL, Argentina, under Source, Carrier, Fiberoptic Light. 6 manufacturers in China are registered for this product code.

Registry build 21.09.26
6manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Jiangsu (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EQH
Manufacturer City Province Registered as Device types
Beijing Fanxing Guangdian Medical Treatment Equipment Co Ltd Beijing Beijing Contract manufacturer 5
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Shenzhen Eyco Technology Co., Ltd. Shenzhen Guangdong Manufacturer 27
Anhui Shiyin Photoelectric Instrument Co., Ltd. Suzhou Anhui Specification developer 18
Guangzhou T.K Medical Instrument Co., Ltd. Guangzhou Guangdong Contract manufacturer 7
Shenzhen Shanglaite Electronic Technology Co., Ltd. Shenzhen Guangdong Remanufacturer 4

Record

Regulatory record for Everlux PRO
Listed by Ecleris SRL, Argentina
FDA product code EQH
Device type Source, Carrier, Fiberoptic Light
Device class Class 1
Regulation 21 CFR 874.4350
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2022-06-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number
Storage Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -30 to 45 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment humidity 35 to 75 % RH

Catalogue Numbers

Catalogue numbers for Everlux PRO
Catalogue number Size Status
R00 In distribution
R00 In distribution
R00 In distribution
R00 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Pilling Teleflex Medical LLC 216
Jedmed Jedmed Instrument Company 80
Millennium Avalign Technologies, Inc. 72
Ambler Surgical Ambler Surgical, LLC 40
Elmed Incorporated Elmed, Inc. 36
Fentex Fentex medical GmbH 36
MicroFrance® Integra Microfrance SAS 24
Elmed Elmed, Inc. 23
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 19
Source, Carrier, Fiberoptic Light Schölly Fiberoptic GmbH 17
BR Surgical, LLC BR Surgical LLC 16
Bear Mytamed, Inc. 12

Showing 12 of 50. All products under Source, Carrier, Fiberoptic Light

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