Underpad Integrity Plus

Underpad Integrity Plus 1PLY 33X36 Laminated Similar TO 59784100

Registry build 21.09.26
89manufacturers in China registered for this device type
11catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (23), Jiangsu (20), Guangdong (12). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMW
Manufacturer City Province Registered as Device types
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Jiangsu Keling Medical Appliances Co., Ltd. Yangzhou Jiangsu Contract manufacturer 23
Jiangyin Huashi Medical Equipment Co., Ltd. Jiangyin Jiangsu Contract manufacturer 21
Dongguan China Effort Healthcare Products Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Changzhou Care-DE Sanitary Material Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Hubei Haixin Protective Products Group Co., Ltd. Songzi Hubei Contract manufacturer 10
Shenzhen Lantise Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Changzhou Hongtai Paper Film Co., Ltd. Changzhou Jiangsu Contract manufacturer 9
Suzhou Baili Medical Supplies Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Jiangsu Hanfang Textile Technology Co., Ltd. Xuzhou Jiangsu Contract manufacturer 8
Jinhua Yueer ART Craft Co., Ltd. Jinhua Zhejiang Contract manufacturer 6
Haining Yikang Textile Co., Ltd. Haining Zhejiang Contract manufacturer 5

Showing 12 of 89. All 89 manufacturers in China registered for Cover, Mattress (Medical Purposes)

Record

Regulatory record for Underpad Integrity Plus
Listed by Standard Textile Co., Inc., United States
FDA product code FMW
Device type Cover, Mattress (Medical Purposes)
Device class Class 1
Regulation 21 CFR 880.6190
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-01-29
Record revised 2024-12-24 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number
Distribution end date 2024-12-17

Catalogue Numbers

Catalogue numbers for Underpad Integrity Plus
Catalogue number Size Per pack Status
597C1800 24 In distribution
59782100 24 In distribution
597U0200 24 In distribution
59784100 24 In distribution
59797900 24 Withdrawn
5978280L 24 Withdrawn
5978214G 24 Withdrawn
5978254R 24 Withdrawn
597821M9 24 Withdrawn
59782E52 24 Withdrawn
597841Q3 24 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
C-Matt Casco Manufacturing Solutions, Inc. 171
Underpad Quilted Ibex Standard Textile Co., Inc. 68
Cmatt Casco Manufacturing Solutions, Inc. 43
Casco Casco Manufacturing Solutions, Inc. 35
Underpad Quilted Standard Textile Co., Inc. 29
SelectAir Moxi Enterprises, LLC 28
Alleset GRI Medical & Electronic Technology Co., Ltd. 20
Drivemedical Drive DeVilbiss Healthcare 19
Underpad Integrity Standard Textile Co., Inc. 18
CT Gantry Cover Pearl Inc. 16
ProtectYou2 Moxi Enterprises, LLC 13
Excel Plus Comply Quilted PAD Standard Textile Co., Inc. 12

Showing 12 of 244. All products under Cover, Mattress (Medical Purposes)

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