Underpad Quilted

Underpad Quilted Poly Blue/GRN 34X48 Euro Tech Laminated W/PU Barrier

Registry build 21.09.26
89manufacturers in China registered for this device type
29catalogue 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 Quilted
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 2023-07-25 (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 Quilted
Catalogue number Size Per pack Status
597X6900 24 In distribution
59752114 24 In distribution
59703310 24 In distribution
59750101 24 In distribution
59810100 24 In distribution
597L0100 24 In distribution
59740100 24 In distribution
59755210 24 In distribution
59740200 24 In distribution
59750100 24 In distribution
59740201 24 In distribution
597E0200 24 Withdrawn
59745100 24 Withdrawn
597F4700 24 Withdrawn
597G5400 24 Withdrawn
5975522B 24 Withdrawn
59755M18 24 Withdrawn
59701100 24 Withdrawn
59720100 24 Withdrawn
59752AM9 24 Withdrawn
5975063K 24 Withdrawn
597E9201 24 Withdrawn
597H1000 24 Withdrawn
59760000 24 Withdrawn
597F8101 24 Withdrawn
59721500 24 Withdrawn
59736400 24 Withdrawn
597501H9 24 Withdrawn
597H9400 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
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
Sures Vive Health LLC 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