Hans Biomed Usa Inc

FDA Filings

This page includes the latest FDA filings for Hans Biomed Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008778066
• FEI Number: 3008778066
• Name: HANS BIOMED USA, INC.
• Owner & Operator: Hans Biomed USA, Inc.
• Contact Address: 140 Sylvan Ave Suite #301 ; Englewood Cliffs NJ 07632 US
• Official Correspondent:
  • Hyeon-Gyu Park
  • 1-201-2242333-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 140 Sylvan Ave Ste 301 ; Englewood Cliffs, NJ 07632 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K151271 | MQV HANS BIOMED USA, INC.	BellaFuse	2019-12-12
PMN K151271 | MBP HANS BIOMED USA, INC.	BellaFuse	2019-12-12
PMN K130191 | NEW HANS BIOMED USA, INC.	MINT	2019-12-12
MDA HANS BIOMED USA, INC.	SacrClinic(tm)-Gel	2015-07-02
MDA HANS BIOMED USA, INC.	SCAR CLINIC	2015-07-02
MDA HANS BIOMED USA, INC.	SCAR CLINIC-THIN	2015-07-02

Similar & Related FDA Registered Companies

• HansBiomed USA, Inc.