Kenex

354/P/88-207/LR 85cm X 80cm center mounted shield with patient contour corner cut out and curtain.

Registry build 21.09.26
2manufacturers in China registered for this device type
69catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EAK
Manufacturer City Province Registered as Device types
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
Zhengzhou Henghao Optical Technology Co., Ltd. Zhengzhou Henan Manufacturer 6

Record

Regulatory record for Kenex
Listed by Kenex (Electro-Medical) Ltd., United Kingdom
FDA product code EAK
Device type Screen, Leaded, Operator Radiation Protector
Device class Class 1
Regulation 21 CFR 892.6500
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-07-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for Kenex
Catalogue number Size Status
354/76-001 In distribution
354/LR/61 In distribution
354/P/76-006 In distribution
350/45-001/P In distribution
354/P/76-007 In distribution
354/P/LR In distribution
351/68-001 In distribution
351/45-001 In distribution
350/45/LED130F-001 In distribution
351/LR/80 In distribution
351/P68/LED130F-001 In distribution
350/34-0031 In distribution
350/45-0031 In distribution
351/LR/80/SP/30 In distribution
3001/TC/250 In distribution
351/68-006 In distribution
354/P76/LED130F-001 In distribution
350/45-013 In distribution
351/P/68-006 In distribution
354/45-001 In distribution
351/P68/LED130F-0031 In distribution
351/LR/50/SP/40 In distribution
350/34/LED150F-0031 In distribution
351/P/68-001 In distribution
3001/TC/420/3000 In distribution
350/45/LED150F-0031 In distribution
354/P/76-001 In distribution
351/45-0031 In distribution
354/LR/50 In distribution
351/P/68-0031 In distribution
354/P76/LED150F-0031 In distribution
354/P/LR/30 In distribution
354/76-006 In distribution
351/LR/80/SP In distribution
351/LR/50/SP In distribution
350/45/LED130F-0031 In distribution
351/45-006 In distribution
350/34-007 In distribution
351/68-0031 In distribution
351/P/68-007 In distribution
350/45-007 In distribution
350/45/LED150F-001 In distribution
300/LP110/005-3 In distribution
300/P/014 In distribution
354/P/76-207 In distribution
354/45-0031 In distribution
354/P/76-107 In distribution
354/P76/LED3DF-001 In distribution
350/45-001/SP In distribution
300/P/004 In distribution
354/P/88-207/LR In distribution
351/LR/50 In distribution
350/45-001 In distribution
350/45-006 In distribution
350/34-001 In distribution
3001/TC/420/EC In distribution
354/P/88-001 In distribution
3001/TC/250/EC In distribution
354/P76/LED130F-0031 In distribution
351/P68/LED150F-0031 In distribution
3001/TC/420 In distribution
351/68/LED130F-0031 In distribution
354/P/LR/88 In distribution
300/P/012 In distribution
351/P/LR In distribution
354/P76/LED150F-001 In distribution
351/P/LR/SP In distribution
354/76-0031 In distribution
354/P/76-0031 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Aadco Aadco Medical, Inc. 101
OT Mavig Gmbh 64
Drape Burlington Medical, LLC 7
Hercules Medium Duty Suspension System Aadco Medical, Inc. 5
Porta Shield Burlington Medical, LLC 4
Rampart Rampart IC, Inc 4
Clear Lead Barrier Biodex Medical Systems, Inc. 3
Screen, Leaded, Operator Radiation Protector Steris Corporation 2
Techno-Aide Techno-Aide, Inc. 2
Steradian Shield Radux Devices Inc 1
ExoShield Northstar Medical Radioisotopes, LLC 1
Rolling Radiation Shield Alimed, LLC 1

Showing 12 of 21. All products under Screen, Leaded, Operator Radiation Protector

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