Hahnenkratt

ERGOtouch Explorers, glassfiber + stainless steel Form D with handle pastel lavender

Registry build 21.09.26
8manufacturers in China registered for this device type
86catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EKB
Manufacturer City Province Registered as Device types
Amedcon Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Elite Dental LAB Huizhou Guangdong Manufacturer 18
Shumei Industrial (Hebei) Co., Ltd. Cangzhou Hebei Contract manufacturer 10
Guang Zhou Medclear Medical Device Service Co., Ltd. Dongguan Guangdong Contract manufacturer 9
Pengbo (Shenzhen) Medical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for Hahnenkratt
Listed by E. Hahnenkratt Gmbh, Germany
FDA product code EKB
Device type Explorer, Operative
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2024-08-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Latex Contains natural rubber latex
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Hahnenkratt
Catalogue number Size Status
541C In distribution
621D In distribution
544A In distribution
600D In distribution
544D In distribution
546C In distribution
667DF In distribution
622G In distribution
542F In distribution
544F In distribution
541D In distribution
546D In distribution
600C In distribution
543A In distribution
624G In distribution
543D In distribution
626A In distribution
623F In distribution
542C In distribution
545F In distribution
624F In distribution
600A In distribution
544C In distribution
546G In distribution
624D In distribution
540A In distribution
621A In distribution
B600D In distribution
623C In distribution
623A In distribution
540D In distribution
620A In distribution
626C In distribution
620D In distribution
667AG In distribution
600G In distribution
545D In distribution
621C In distribution
B600A In distribution
667AC In distribution
625D In distribution
624C In distribution
540F In distribution
620C In distribution
545A In distribution
624A In distribution
625A In distribution
540C In distribution
545C In distribution
B600G In distribution
622C In distribution
625F In distribution
541A In distribution
546F In distribution
667FG In distribution
542G In distribution
543F In distribution
620G In distribution
545G In distribution
622F In distribution
542A In distribution
544G In distribution
625G In distribution
623D In distribution
543C In distribution
620F In distribution
546A In distribution
667AD In distribution
623G In distribution
626F In distribution
541F In distribution
622A In distribution
B600F In distribution
621F In distribution
600F In distribution
543G In distribution
626D In distribution
622D In distribution
625C In distribution
540G In distribution
B600C In distribution
542D In distribution
541G In distribution
626G In distribution
667AF In distribution
621G In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Nordent Manufacturing Inc Nordent Manufacturing Inc 207
HU-Friedy HU-Friedy MFG Co., LLC 196
Integra® Miltex® Integra LifeSciences Production Corporation 67
Power Dental USA Power Dental U.S.A. Inc. 42
Sklar® Sklar Corporation 39
Premier Explorers Premier Dental Products Co. 35
Darby Dental Supply, LLC Darby Dental Supply, LLC 32
Brasseler USA Peter Brasseler Holdings, LLC 30
Zoll-Dental Zoll-Dental 29
National Distribution & Contracting Inc. Nordent Manufacturing Inc 28
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 26
Burkhart Dental Nordent Manufacturing Inc 25

Showing 12 of 77. All products under Explorer, Operative

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