S300 Series

AC 100-240V, 50/60Hz, 61-84 VA(Non Camera)

Registry build 21.09.26
6manufacturers in China registered for this device type
41catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FTD
Manufacturer City Province Registered as Device types
Shanghai Huifeng Medical Instrument Co., Ltd. Shanghai Shanghai Contract manufacturer 4
Dragon Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 48
Shenzhen Comen Medical Instruments Co., Ltd. Shenzhen Guangdong Contract manufacturer 24
HI-Life Technology (Hebei) Co., Ltd. Bazhou Hebei Manufacturer 11
Shenzhen Youmay Electronics Co., Ltd. Shenzhen Guangdong Manufacturer 10
Shanghai PAX Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 7

Record

Regulatory record for S300 Series
Listed by Dentis Co., Ltd., South Korea
FDA product code FTD
Device type Lamp, Surgical
Device class Class 2
Regulation 21 CFR 878.4580
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2025-02-19

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 S300 Series
Catalogue number Size Status
S300-37001 In distribution
S300-36001 In distribution
S300-23100 In distribution
S300-37000 In distribution
S300-21001 In distribution
S300-30000 In distribution
S300-31101 In distribution
S300-24100 In distribution
S300-24101 In distribution
S300-24001 In distribution
S300-20000 In distribution
S300-31001 In distribution
S300-A0000 In distribution
S300-20100 In distribution
S300-25000 In distribution
S300-21000 In distribution
S300-22000 In distribution
S300-31000 In distribution
S300-32000 In distribution
S300-22101 In distribution
S300-36000 In distribution
S300-31100 In distribution
S300-23000 In distribution
S300-36101 In distribution
S300-36100 In distribution
S300-37101 In distribution
S300-23001 In distribution
S300-23101 In distribution
S300-25001 In distribution
S300-21100 In distribution
S300-37100 In distribution
S300-24000 In distribution
S300-22100 In distribution
S300-25100 In distribution
S300-21101 In distribution
S300-A0010 In distribution
S300-32001 In distribution
S300-32100 In distribution
S300-22001 In distribution
S300-30100 In distribution
S300-25101 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Maquet PowerLED II Maquet Gmbh 1,930
Standop Volista® Maquet Gmbh 32
L400 Series Dentis Co., Ltd. 24
M400 Series (Ceiling, Mobile) Dentis Co., Ltd. 24
Lamp, Surgical Maquet Gmbh 18
Maquet Ezea Maquet Gmbh 18
Maisilide Shandong Deman Medical Equipment Group Co., Ltd. 15
S250 Series(Ceiling, Mobile) Dentis Co., Ltd. 11
Lucea LED® Maquet Gmbh 7
StarTrol Huot Instruments, LLC 7
Rolite Volista Standop Maquet Gmbh 5
Lewin Shandong Lewin Medical Equipment Co., Ltd. 5

Showing 12 of 52. All products under Lamp, Surgical

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