DeRoyal

Custom PolybagSize: 8 x 10 inches

Registry build 21.09.26
45manufacturers in China registered for this device type
167catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (12), Zhejiang (11), Shanghai (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KDC
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Xiantao Daoqi Plastic Co., Ltd. Xiantao Hubei Contract manufacturer 16
Nantong City Yojo Medical Products Co., Ltd. Haimen Jiangsu Contract manufacturer 14
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Anhui Medfaith Medical Devices Co., Ltd. Tianchang Anhui Contract manufacturer 6
Shanghai Kohope Medical Devices Co., Ltd. Shanghai Shanghai Contract manufacturer 4
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82

Showing 12 of 45. All 45 manufacturers in China registered for Instrument, Surgical, Disposable

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code KDC
Device type Instrument, Surgical, Disposable
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-07-12
Record revised 2023-05-03 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 100, case of 50, box of 50, case of 20, case of 4
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Status
32-1969 In distribution
30-702NS In distribution
32-1361 In distribution
25-0201NS In distribution
25-0101EU In distribution
25-0108NS In distribution
25-0701 In distribution
25-1104YNS In distribution
25-0401 In distribution
25-1401Y In distribution
77-301370 In distribution
25-1104EUN In distribution
25-0108EU In distribution
30-810NS In distribution
30-702 In distribution
88-000005 In distribution
25-1401EU In distribution
31-097 In distribution
25-0101 In distribution
10045704 In distribution
25-1702EU In distribution
25-302NS In distribution
25-1504 In distribution
25-1801NS In distribution
25-0103NS In distribution
31-257 In distribution
25-1104Y In distribution
30-705NS In distribution
25-001NS-T In distribution
25-1701NS In distribution
25-0901NS In distribution
25-1702 In distribution
25-0105EU In distribution
25-0803 In distribution
31-283 In distribution
25-012NS In distribution
25-0702NS In distribution
32-1144 In distribution
25-0900 In distribution
25-0502NS In distribution
25-0501NS In distribution
25-303 In distribution
25-0402 In distribution
32-303 In distribution
25-1403NS In distribution
25-0403 In distribution
25-0402NS In distribution
25-1401EUN In distribution
25-0104 In distribution
31-195 In distribution
V77-301371 In distribution
30-703NS In distribution
25-0103EUN In distribution
25-0104NS In distribution
25-1403EU In distribution
25-1104EU In distribution
32-1344 In distribution
31-054 In distribution
25-0802EU In distribution
25-0401EU In distribution
25-0104EUN In distribution
25-0801EU In distribution
30-703 In distribution
25-0401NS In distribution
32-196 In distribution
25-0108 In distribution
D6200NS In distribution
25-1701 In distribution
25-0802NS In distribution
25-1401YNS In distribution
25-0103 In distribution
32-1547 In distribution
25-001NS In distribution
25-0402EUN In distribution
25-0201EU In distribution
88-000008 In distribution
32-1179 In distribution
25-303NS In distribution
25-002NS In distribution
25-1504NS In distribution
30-701 In distribution
25-0402EU In distribution
25-1407NS In distribution
25-3101 In distribution
25-0403EUN In distribution
30-705 In distribution
77-301371N In distribution
32-1301 In distribution
77-301370N In distribution
32-635 In distribution
25-1803NS In distribution
25-0801NS In distribution
25-0103EU In distribution
25-001 In distribution
25-1104NS In distribution
25-1401 In distribution
25-0801 In distribution
25-003NS In distribution
31-611 In distribution
32-158 In distribution
25-002 In distribution
25-0108W In distribution
25-1403 In distribution
32-1235 In distribution
30-810 In distribution
32-1084 In distribution
17-044 In distribution
32-155 In distribution
32-1133 In distribution
25-0401EUN In distribution
25-0101NS In distribution
25-003 In distribution
32-661 In distribution
25-1108EUN In distribution
25-0403NS In distribution
25-1702EUN In distribution
25-302 In distribution
32-1252 In distribution
25-1108 In distribution
25-1502 In distribution
31-218 In distribution
25-0403EU In distribution
25-0101EUN In distribution
25-0301 In distribution
32-1092 In distribution
30-800 In distribution
32-1178 In distribution
25-1502NS In distribution
9810-01 In distribution
25-011NS In distribution
25-004 In distribution
25-1108NS In distribution
25-1801 In distribution
31-283NS In distribution
25-0105 In distribution
25-0201 In distribution
30-706 In distribution
32-1721 In distribution
9810-00 In distribution
32-965 In distribution
25-1108EU In distribution
30-704 In distribution
25-0104WNS In distribution
25-1401YEU In distribution
25-1403EUN In distribution
77-301371 In distribution
25-0803NS In distribution
25-0301NS In distribution
25-1702NS In distribution
25-0108WNS In distribution
25-0104EU In distribution
V77-301370 In distribution
25-0900NS In distribution
25-0901 In distribution
32-1723 In distribution
25-011 In distribution
30-701NS In distribution
25-0504 In distribution
25-0501 In distribution
25-1407 In distribution
25-0702 In distribution
25-0502 In distribution
25-0802 In distribution
25-1104 In distribution
30-704NS In distribution
32-170 In distribution
25-0701NS In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bioseal Inc. Bioseal 213
Medical Action Industries Medical Action Industries, Inc. 112
Centurion Centurion Medical Products Corporation 98
MSI Precision Specialty Instruments MED Saver, Inc. 77
Sterion® Vessel Loop Aspen Surgical Products, Inc. 47
Sterion®Clamp Cover Fabric Aspen Surgical Products, Inc. 31
Integra Provision 26
Devon Cardinal Health 25
Instrument, Surgical, Disposable Summit Medical LLC 23
Dermapac, Inc. Dermapac Inc. 22
CareFusion 2200 Provision 20
Medline Medline Industries, Inc. 20

Showing 12 of 155. All products under Instrument, Surgical, Disposable

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