DeRoyal

Syringe 10CC Adenosine Purple 50C

Registry build 21.09.26
7manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Beijing (2), Guangdong (2).

Chinese manufacturers registered for FDA product code IZI
Manufacturer City Province Registered as Device types
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Scivita Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 19
Siemens Shanghai, Medical Equipment Ltd. Shanghai Shanghai Contract manufacturer 10
Guangdong Optomedic Technologies, Inc. Foshan Guangdong Manufacturer 7
Zhuhai Dipu Medical Technology Co., Ltd. Zhuhai Guangdong Manufacturer 3

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code IZI
Device type System, X-Ray, Angiographic
Device class Class 2
Regulation 21 CFR 892.1600
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2016-09-12
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 50, case of 10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Status
77-400602 In distribution
77-400102 In distribution
77-400104 In distribution
77-400100 In distribution
77-400065 In distribution
77-400598 In distribution
77-400601 In distribution
77-400115 In distribution
77-400101 In distribution
77-400103 In distribution
77-400600 In distribution
77-400033 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sterimed Sterimed, Inc. 114
Med-Syringe Argon Medical Devices, Inc. 16
Control Syringe Argon Medical Devices, Inc. 14
Novadaq and Pinpoint Novadaq Technologies, Inc. 12
Namic Navilyst Medical, Inc. 9
Namic Medline Industries, Inc. 8
iMRX System Imris Imaging, Inc. 6
System, X-Ray, Angiographic B. Braun Medical Inc. 4
System, X-Ray, Angiographic Intuitive Surgical, Inc. 3
Leica FL800 Leica Microsystems (Schweiz) AG 3
Infrared 800 with Flow® 800 Option Carl Zeiss Meditec Inc 2
Leica FL800 ULT Leica Microsystems (Schweiz) AG 2

Showing 12 of 51. All products under System, X-Ray, Angiographic

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