Kenex

312/DS-042/1 118cm x 75cm curtain shield with top shields 3.32, 3.30 & 3.41

Registry build 21.09.26
78manufacturers in China registered for this device type
163catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (19), Jiangsu (13), Guangdong (10). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KPY
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Jiangsu Hanheng Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 20
Honghu Danielle Sanitary Material Co., Ltd. Honghu Hubei Contract manufacturer 12
Primed Liyang Medical Products Manufacturing Co., Ltd. Liyang Jiangsu Contract manufacturer 11
Taijia Medical Electronics (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Gushi priMED Medical Products Manufacturing Co., Ltd. Gushi County Henan Contract manufacturer 9
Wenzhou Weilan Optical Co., Ltd. Wenzhou Zhejiang Contract manufacturer 8
priMED Jiujiang Medical Products Manufacturing Co., Ltd. Jiujiang Jiangxi Contract manufacturer 7
Skytech Electronics (HK) Limited Tsim Sha Tsui Hong Kong Contract manufacturer 5
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146

Showing 12 of 78. All 78 manufacturers in China registered for Shield, Protective, Personnel

Record

Regulatory record for Kenex
Listed by Kenex (Electro-Medical) Ltd., United Kingdom
FDA product code KPY
Device type Shield, Protective, Personnel
Device class Class 1
Regulation 21 CFR 892.6500
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-07-13
Record revised 2024-01-31 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Latex Labelled latex-free
Label carries serial number
Distribution end date 2025-01-06

Catalogue Numbers

Catalogue numbers for Kenex
Catalogue number Size Status
312/DS-039/2-1 In distribution
312/W-LBT In distribution
311/S-TOP In distribution
312/E-013 In distribution
312/DS-039/2-2 In distribution
312/E-021/8 In distribution
312/E-016 In distribution
312/E-010 In distribution
312/E-016/P In distribution
312/E-020/SP90 In distribution
102/C/11 In distribution
312/E-015/102 In distribution
313/A2-017 In distribution
312/DS/3.130 In distribution
311/DS-020/SP/90 In distribution
312/E-017/8P In distribution
312/E-022 In distribution
100/428 In distribution
312/DS-041/2 In distribution
100/1 In distribution
312/E-007 In distribution
312/E-006/P In distribution
312/DS/3.167 In distribution
312/E-012 In distribution
312/E-023/8P In distribution
312/DS/3.32/3 In distribution
312/DS-039/10 In distribution
312/DS-039/4 In distribution
312/DS-04112/6 In distribution
312/E-021/82 In distribution
312/DS-039/6 In distribution
312/DS-039/5-SP In distribution
312/W-LB In distribution
312/E-020/3 In distribution
312/E/3.30 In distribution
312/DS-039/5-1 In distribution
312/DS-0412/6 In distribution
312/DS-0412/1 In distribution
312/DS/3.30 In distribution
100/2L In distribution
312/E-011/P In distribution
312/DS-039/1 In distribution
312/DS/3.42 In distribution
312/DS-039/10/4 In distribution
312/E-016/8 In distribution
312/DS/3.135 In distribution
313/A2-011 In distribution
312/E-017 In distribution
313/A2-024 In distribution
312/E-010/P In distribution
312/DS-060 In distribution
312/DS-039/5/8 In distribution
313/A2-016 In distribution
312/E-015/82 In distribution
312/DS-0412/4 In distribution
312/DS-0522/1 In distribution
313/A2-014 In distribution
103 In distribution
100/4L In distribution
100/3R In distribution
312/E-020 In distribution
312/E-015/8 In distribution
312/DS/3.138 In distribution
313/A3-002 In distribution
312/DS/3.115 In distribution
313/A2-018 In distribution
312/DS-099 In distribution
312/E-020/8 In distribution
312/DS-039/5 In distribution
312/DS/3.33 In distribution
312/E-023 In distribution
312/E-023/8 In distribution
312/E-020/8P In distribution
312/E-016/8P In distribution
312/DS/3.108 In distribution
100/5L In distribution
312/E-021/102 In distribution
311/DS/TOP In distribution
312/DS/3.110 In distribution
312/DS-041/1 In distribution
312/E/027 In distribution
312/DS/3.139 In distribution
313/A2-025 In distribution
100/4R In distribution
312/DS-007 In distribution
312/DS/3.41 In distribution
312/DS/3.106 In distribution
312/E-023/P In distribution
100/2R In distribution
312/DS-039/9 In distribution
312/E-040/P In distribution
312/E-013/P In distribution
312/DS-040/2 In distribution
312/E-022/P In distribution
312/E-021/8P In distribution
312/E-017/8 In distribution
1342/A2/E-001 In distribution
312/DS-070 In distribution
312/DS-039/2 In distribution
312/DS-039/6/3 In distribution
312/E-020/3/P In distribution
312/E-006 In distribution
1342/A2/F In distribution
312/E/024 In distribution
312/DS-008 In distribution
313/A2-023 In distribution
106 In distribution
312/DS-042/1 In distribution
312/DS/3.32 In distribution
312/DS/3.122 In distribution
312/E-022/8P In distribution
312/DS-008/3 In distribution
313/A2/3.28 In distribution
312/E-021/2 In distribution
313/A3-001 In distribution
1342/A3/E-001 In distribution
102/C/06 In distribution
312/E-021/P In distribution
312/E-015 In distribution
313/A2/3.34 In distribution
312/DS-071 In distribution
312/E-015/8P In distribution
312/E/025 In distribution
312/E-040 In distribution
311/DS-020A In distribution
313/A2-001 In distribution
312/E-020/P In distribution
313/A2-008 In distribution
312/E-005 In distribution
311/TC/004 In distribution
312/E-005/P In distribution
312/DS-039/5/9 In distribution
313/A2-010 In distribution
312/W-TOP In distribution
312/E-015/2 In distribution
100/5R In distribution
312/DS-040/1 In distribution
312/DS-039/6/3/SP In distribution
312/E-015/P In distribution
312/DS-0412/5 In distribution
313/A3-001/W In distribution
311/DS-020 In distribution
312/E-022/8 In distribution
312/DS/3.128 In distribution
312/E-011 In distribution
312/DS-006 In distribution
312/E-021 In distribution
312/DS-0412/2 In distribution
313/A2/3.24 In distribution
313/A2-020 In distribution
312/E-010/SP In distribution
313/A2-021 In distribution
312/DS-039/4/3 In distribution
312/E-012/P In distribution
311/W In distribution
312/E-017/P In distribution
312/DS-060/1/3 In distribution
313/A2-019 In distribution
312/DS/3.32/2 In distribution
312/E-015/SP In distribution
100/3L In distribution
312/DS-039/9/4 In distribution
313/A2-022 Withdrawn

Same Product Code

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Sleeve Burlington Medical, LLC 51
Lead Lined Biodex Medical Systems, Inc. 40
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Halyard Scatter Radiation Shields Angiosystems, Inc. 30
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Showing 12 of 134. All products under Shield, Protective, Personnel

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