Elmed

Reusable Foley Style Catheter Tip Punch used for cutting 3mm dia. round hole I distal tip End of Foley Uterine Catheter. Body light- weight aluminum construction. 25mm x 40mm. Autoclavable…

Registry build 21.09.26

Reusable Foley Style Catheter Tip Punch used for cutting 3mm dia. round hole I distal tip End of Foley Uterine Catheter. Body light- weight aluminum construction. 25mm x 40mm. Autoclavable Medical Grade Stainless Steel and Aluminum.

11manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (5), Guangdong (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NWW
Manufacturer City Province Registered as Device types
Guangdong MacroLux Medical Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 9
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24
Anhui Shiyin Photoelectric Instrument Co., Ltd. Suzhou Anhui Specification developer 18
Zhuji Pengtian Medical Instrument Co., Ltd. Zhuji Zhejiang Manufacturer 10
Macrolux Medical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9
Guangzhou RED Pine Medical Instrument Co., Ltd. Guangzhou Guangdong Manufacturer 8
Suzhou Acuvu Medical Technology Co., Ltd. Suzhou Jiangsu Specification developer 4
Jiangsu Jiyuan Medical Technology Co., Ltd. Taizhou Jiangsu Specification developer 3
Origyn Medical Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Specification developer 2

Record

Regulatory record for Elmed
Listed by Elmed, Inc., United States
FDA product code NWW
Device type Hysteroscope Accessories
Device class Class 1
Regulation 21 CFR 884.1690
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-01-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Elmed
Catalogue number Size Status
31937-33 In distribution
31937-56 In distribution
31937-54 In distribution
ST3167060 In distribution
ST3153424 In distribution
ST3153434 In distribution
ST310440 In distribution
31670-60 In distribution
31940-21 In distribution
51500-34 In distribution
51290-15 In distribution
31534-36 In distribution
SM31-0919GL In distribution
31534-24 In distribution
31400-17A In distribution
51300-33 In distribution
ST3140017B In distribution
31940-22 In distribution
31400-17B In distribution
31526-33 In distribution
31-04-40 In distribution
ST3193754 In distribution
31540-32 In distribution
ST3193756 In distribution
ST3153436 In distribution
ST3152633 In distribution
31540-34 In distribution
ST3154034 In distribution
ST3154032 In distribution
ST3140017A In distribution
ST3193733 In distribution
ST3194021 In distribution
31534-34 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 55
OriGynMED Origyn Medical Technology (Hangzhou) Co., Ltd. 36
Strauss Surgical American Medical Endoscopy 16
Olympus Olympus Winter & IBE Gmbh 9
Clickline Karl Storz GmbH & Co. KG 9
Hysteroscope Accessories Karl Storz GmbH & Co. KG 8
Hysteroscope Accessories Henke-Sass Wolf, Gmbh. 7
Elmed Incorporated Elmed, Inc. 6
Hermann Medizintechnik GmbH Hermann Medizintechnik Gmbh 5
Hysteroscope Accessories Boston Scientific Corporation 4
Pneumostop® LSI Solutions Inc. 4
Single-use Endoscopic Scissors Macrolux Medical Technology Co., Ltd. 3

Showing 12 of 50. All products under Hysteroscope Accessories

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