Equimat

Equimat® SCB

Registry build 21.09.26
8manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LJH
Manufacturer City Province Registered as Device types
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Changzhou DSB Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Jiangsu Shenli Medical Production Co., Ltd. Changzhou Jiangsu Contract manufacturer 6
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Suzhou Prosteri Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 20

Record

Regulatory record for Equimat
Listed by Karl Storz GmbH & Co. KG
FDA product code LJH
Device type System, Irrigation, Urological
Device class Class 2
Regulation 21 CFR 876.5130
Record published 2016-09-23
Record revised 2024-10-21 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Equimat
Catalogue number Size Status
20302020-1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Irrigation Set B. Braun Medical Inc. 11
Medline Medline Industries, Inc. 6
MED-RX Canadian Hospital Specialties Ltd. 3
AMSure ® Four Lead Bladder Irrigation Set Amsino Medical Inc. 2
Asurys™ Boston Scientific Corporation 2
AMSure® Cystoscopy/Bladder Irrigation Set Amsino Medical Inc. 2
Arthromatic/Uromatic Baxter Healthcare Corporation 1
Flo-Assist II Northgate Technologies Inc. 1
Centurion Centurion Medical Products Corporation 1
Avid TruCustom Avid Medical, Inc. 1
System, Irrigation, Urological Karl Storz GmbH & Co. KG 1
AMSure® TUR/Bladder Irrigation Set Y-Type Amsino Medical Inc. 1

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