DeRoyal

Custom Dental Packing 10/PK

Registry build 21.09.26
107manufacturers in China registered for this device type
18catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (23), Zhejiang (20), Anhui (14). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EFN
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21
Jiujiang Huada Medical Dressing Co., Ltd. Jiujiang Jiangxi Contract manufacturer 18
Kingstar Medical (Xianning) Co., Ltd. Xianning Hubei Contract manufacturer 17
Jiangsu Likang Medical Products Co., Ltd. Wujiang Jiangsu Contract manufacturer 17
Kingstar Industries (Wuhan) Co., Ltd. Wuhan Hubei Contract manufacturer 10
Winner Medical (Jiayu) Co., Ltd. Jiayu Hubei Contract manufacturer 7
Dalian Wenjing Wooden Industry Co., Ltd. Dalian Liaoning Contract manufacturer 6

Showing 12 of 107. All 107 manufacturers in China registered for Cotton, Roll

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code EFN
Device type Cotton, Roll
Device class Class 1
Regulation 21 CFR 872.6050
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-07-12

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 20, case of 50, case of 100, case of 40, case of 25, case of 250
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Per pack Status
32-890 In distribution
30-131 In distribution
32-1164 In distribution
32-1375 In distribution
32-2068 In distribution
32-190 2 In distribution
17-1018 In distribution
32-886 In distribution
17-9936 In distribution
31-207 In distribution
30-419 In distribution
32-1071 In distribution
32-1374 In distribution
17-1016 In distribution
30-096 In distribution
17-6708 In distribution
32-891 In distribution
32-641 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 15
Henry Schein Henry Schein, Inc. 13
Cardinal Health Cardinal Health 200, LLC 11
Supplies American Orthodontics 10
Safe Dent Bgss Company Inc 4
JMU JMU Dental, Inc 4
Burkhart Non-Woven Sponges Crosstex International 3
Cotton Roll Holders American Orthodontics 3
Monoart Euronda SPA 3
Cylindrical Sponge American Surgical Company, LLC 3
Crosstex International Crosstex International 3
National Hospital Packaging Surgi-Pak, Inc. 3

Showing 12 of 47. All products under Cotton, Roll

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