DeRoyal

Gait Belt, Heavy DutyTiger Teeth Buckle, 2 In X 70 In

Registry build 21.09.26
118manufacturers in China registered for this device type
24catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (50), Jiangsu (24), Zhejiang (22). 22 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IKX
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Dongguan Hong De Medical Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 32
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Jiangyin Huashi Medical Equipment Co., Ltd. Jiangyin Jiangsu Contract manufacturer 21
Foshan Huafukang Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 19
Shenzhen Zhouyang Medical Care Product Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Tops Medical Articles Industries Nantong Inc Qidong Jiangsu Contract manufacturer 17
Raise Medical Industries, Inc. Foshan Guangdong Contract manufacturer 16
Genteel Homecare Products Co., Ltd. Foshan Guangdong Contract manufacturer 12
Suzhou Suning Underpad Co., Ltd. Suzhou, Jiangsu Province Contract manufacturer 11

Showing 12 of 118. All 118 manufacturers in China registered for Aid, Transfer

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code IKX
Device type Aid, Transfer
Device class Class 1
Regulation 21 CFR 890.5050
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-08-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 25, case of 40, case of 82, case of 60, case of 24
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Status
M5166Y-72 In distribution
M2572 In distribution
M5165 In distribution
M5167 In distribution
M5168-YL In distribution
M5166 In distribution
M5168-Y In distribution
M2616D25 In distribution
M5168 In distribution
MK3045-UBLG In distribution
M5166-84 In distribution
M5166-B In distribution
M2656 In distribution
M2660 In distribution
M5167-B In distribution
M5164 In distribution
M5164-YL In distribution
M5166Y In distribution
400P10 In distribution
M5166-72 In distribution
M2616D01 In distribution
M2672 In distribution
M2672-B In distribution
M2616D72 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Molift Etac A/S 149
Banana Gbuk Group Limited 109
Immedia Etac Immedia A/S 75
Vive Vive Health LLC 56
Condor Grainger International, Inc. 42
Superslide Therafin Corporation 24
Aquasense Drive DeVilbiss Healthcare 24
Select Pressalit A/S 24
Theraslide Therafin Corporation 18
Aquasence Drive DeVilbiss Healthcare 18
Binder Lift We Stitch Stuff, LLC 16
Etac Supply Center AB Etac Supply Center AB 16

Showing 12 of 460. All products under Aid, Transfer

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