Curaplex

Curaplex Heavy Duty Fitted Sheet, 30" x 72", White, 350lbs weight rating, Square Ends, 100gsm, 50/CS

Registry build 21.09.26
308manufacturers in China registered for this device type
37catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (73), Zhejiang (56), Hubei (49). 65 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KME
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21

Showing 12 of 308. All 308 manufacturers in China registered for Bedding, Disposable, Medical

Record

Regulatory record for Curaplex
Listed by Bound Tree Medical, LLC, United States
FDA product code KME
Device type Bedding, Disposable, Medical
Device class Class 1
Regulation 21 CFR 880.6060
Establishment Manufacturer
Premarket notification Exempt
Record published 2024-07-30
Record revised 2024-06-19 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 50, case of 100, case of 10, case of 30
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number Size Per pack Status
3271-62602 In distribution
8600-01303 In distribution
MS-001HS In distribution
MS-42210 In distribution
3271-63202 In distribution
3271-44100 In distribution
14068EA In distribution
BT-42604 In distribution
670222-KIT In distribution
3272-53578 In distribution
3271-36805 In distribution
14043 In distribution
BT-40520 In distribution
670193-KIT In distribution
3271-62002 In distribution
3271-03490EP In distribution
3271-63400 50 In distribution
8600-01325 In distribution
BT-42610 In distribution
3271-63402 50 In distribution
3271-63401 50 In distribution
3271-62402 In distribution
8600-01339 In distribution
30057 In distribution
3271-63403 50 In distribution
MS-001FL In distribution
BT-B200 In distribution
3271-60402EA In distribution
3271-44125 In distribution
3271-63802 In distribution
12945 In distribution
670223-KIT In distribution
16570 In distribution
3271-300LSEP In distribution
8600-01386 In distribution
3271-44150EP In distribution
BT-42612 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Wings Cardinal Health 38
Alleset GRI Medical & Electronic Technology Co., Ltd. 34
PremierPro Prestige Ameritech 22
Allen Hill-ROM, Inc. 20
AllCare Allcare, Inc. 18
Cardinal Health Cardinal Health 200, LLC 18
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 17
Thermoflect Encompass Group, L.L.C. 17
Action® Action Products, Inc. 15
Novaplus Cardinal Health 14
Primo/ASP Medical ASP Global, LLC 13
Emsrun Wuxi Emsrun Technology Co., Ltd. 13

Showing 12 of 228. All products under Bedding, Disposable, Medical

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