SME

Economy Ultrasound Gel 5 Liter

Registry build 21.09.26
8manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (2), Hong Kong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MUI
Manufacturer City Province Registered as Device types
Ming FAI Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
JKH Health Co., Ltd. Dongguan Guangdong Contract manufacturer 22
Jianerkang Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 18
Ming FAI Enterprise International Co., Ltd. Kowloon Hong Kong Exporter 18
Anhui Deepblue Medical Technology Co., Ltd. Hefei Anhui Contract manufacturer 16
Hony Medical Co., Ltd. Taishan Guangdong Contract manufacturer 10
Foshan Pingchuang Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 9
Changzhou Atomic HI-Tech Radiation Co., Ltd. Changzhou Jiangsu Contract manufacturer 8

Record

Regulatory record for SME
Listed by SME, Inc. USA
FDA product code MUI
Device type Media, Coupling, Ultrasound
Device class Class 2
Regulation 21 CFR 892.1570
Premarket notification Exempt
Record published 2016-10-31
Record revised 2026-03-17 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 50 to 80 °F
Sizes Total volume 1 Gallon; total volume 5 l
Distribution end date 2018-05-30

Catalogue Numbers

Catalogue numbers for SME
Catalogue number Size Status
SMEG Total Volume 5 l In distribution
SMEL Total Volume 1 Gallon In distribution
SMEL Total Volume 1 Gallon Withdrawn
SMEG Total Volume 5 l Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Winner EVO Package Drive DeVilbiss Healthcare 36
GelShot Drive DeVilbiss Healthcare 33
Wavelength National Therapy Products Inc. 32
Pharmaceutical Innovations Pharmaceutical Innovations, Inc. 27
Therasound EVO Package Drive DeVilbiss Healthcare 10
Cardinal Health Cardinal Health 200, LLC 7
EcoVue HR Pharmaceuticals Inc. 7
HR Ultrasound Jelly HR Pharmaceuticals Inc. 7
Medline Medline Industries, Inc. 7
Aquasonic Clear Parker Laboratories, Inc. 6
Medichoice Owens & Minor Distribution, Inc. 5
Aquasonic Parker Laboratories, Inc. 5

Showing 12 of 40. All products under Media, Coupling, Ultrasound

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