Xuzhou Kernel Medical Instrument Equipment Co L T D

FDA Filings

This page includes the latest FDA filings for Xuzhou Kernel Medical Instrument Equipment Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008393409
• FEI Number: 3008393409
• Name: XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD
• Owner & Operator: XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD
• Contact Address: Kernel Mansion Economic Development District; Xuzhou CN-32 Jiangsu 221004 CN
• Official Correspondent:
  • Wei Zhao
  • 86-516-87732218-x
• US Agent:
  • Marco Mu
  • Mid-link International Inc
  • 360 3257028
  • 360 9253199
  • us.agent@mid-link.net
• Importing Logistics Registration:
  • Importer: Dox Depot LLC
  • Address: 800 Midland Ave ; Thomasville, NC 27360 UNITED STATES
• Importing Logistics Registration:
  • Importer: EI Medical, Inc
  • Address: 9105C Owens Dr. #102 ; Manassas Park, VA 20111 UNITED STATES
• Importing Logistics Registration:
  • Importer: Gifts From A Far LLC
  • Address: 8033 Sunset Blvd #460 ; Los Angeles, CA 90046 UNITED STATES
• Importing Logistics Registration:
  • Importer: JI Medical,Inc
  • Address: 6026 WILSHIRE BLVD ; Los Angeles, CA 90036 UNITED STATES
• Importing Logistics Registration:
  • Importer: LEANA ORDERS, INC
  • Address: LEONID KRITS 431 TRAVIS AVE ; Staten Island, NY 10314 UNITED STATES
• Importing Logistics Registration:
  • Importer: MONTGOMERY GYNECOLOGY, LLC
  • Address: 115 Plymouth Road, C-1, Suite 5 Plymouth Meeting ; Plymouth Meeting, PA 19462 UNITED STATES
• Importing Logistics Registration:
  • Importer: PAIN MANAGEMENT TECHNOLOGIES
  • Address: 1760 Wadsworth Rd ; Akron, OH 44320 UNITED STATES
• Importing Logistics Registration:
  • Importer: Triton Web Properties
  • Address: 4135 Laguna Street ; Coral Gables, FL 33146 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Kernel Mansion Economic Development District; Xuzhou Jiangsu, 221004 CN
• Establishment Type:
  • Foreign Private Label Distributor
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K180900 | OLP XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	POLY Go	2019-09-23
PMN K181805 | FTC XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	UV phototherapy	2019-02-25
PMN K170187 | GEX XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	POLY Rejuv	2017-08-18
PMN K170187 | GEX XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	POLY Regen	2017-08-18
PMN K170187 | GEX XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	POLY Clear	2017-08-18
GMB XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	KN-9000B	2017-04-08
GMB XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	KN-9000A	2017-04-08
PMN K160341 | HEX XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	Colposcope System	2016-11-22
PMN K132643 | FTC XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	model:KN-4003AL/KN-4003B/KN-4003BL/KN-4006AL/KN-4006B/KN-4006BL	2014-05-27
PMN K132643 | FTC XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD	UV Phototherapy	2014-05-27