Koo Medical Equipment Shanghai Co L T D

FDA Filings

This page includes the latest FDA filings for Koo Medical Equipment Shanghai 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: 9616410
• FEI Number: 3003413553
• Name: KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD.
• Owner & Operator: KOO MFG, INC.
• Contact Address: 100 Zhongde Road Dakun Indurstrial Park; Songjiang CN-31 Shanghai 201613 CN
• Official Correspondent:
  • CHRISTOPHER - KOO
  • 86-21-5785841-x
• US Agent:
  • Matt Dryden
  • Promedic, LLC
  • 239 3076063
  • 239 3076070
  • matt.dryden@promedic.cc
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 100 Zhongde Road, Dakun Industrial Park ; Songjiang Shanghai, 201614 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
CAE KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]	FLEXI CRYSTAL AIRWAY MASK	2007-01-26
CAE KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]	CRYSTAL AIRWAY MASK	2007-01-26
KYZ KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]	MASK INFLATION BULB	2006-04-27
KYZ KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]	Inflation Syringe for Rectal Balloon	2006-04-27
KYZ KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]	BULB SYRINGES	2006-04-27
BSJ KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]	FACE MASK	1999-12-13
BSJ KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]	CRYSTAL ANESTHESIA MASK	1999-12-13
BSJ KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. [KOO MFG, INC.]	ARIA BLOW MOLD MASK	1999-12-13