Ningbo Ouhan Medical Device Co L T D

FDA Filings

This page includes the latest FDA filings for Ningbo Ouhan Medical Device 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: 0
• FEI Number: 0
• Name: Simcal
• Owner & Operator: NINGBO OUHAN MEDICAL DEVICE CO., LTD.
• Contact Address: No.16, West Ruhu Road, Simen Town ; Yuyao CN-33 Zhejiang 315470 CN
• Official Correspondent:
  • Miss Annie
  • 086-057-6213799-9
• US Agent:
  • Simcal
  • UCL-REG SERVICE INC.
  • 347 7030850
  • gbstandard@163.com
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3907 PRINCE STREET SUITE 6F ; Flushing, NY 11354 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K203418 Ningbo Ouhan Medical Device Co., Ltd.	Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))	2021-09-17
LYU Simcal [NINGBO OUHAN MEDICAL DEVICE CO., LTD.]	Disposable medical mask	2020-03-21