Asterasys Co L T D

FDA Filings

This page includes the latest FDA filings for Asterasys 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: 3012451738
• FEI Number: 3012451738
• Name: ASTERASYS Co., Ltd
• Owner & Operator: ASTERASYS Co., Ltd.
• Contact Address: #1005, 25 Seongsuil-ro 4-gil Seongdong-gu; Seoul KR-NOTA 04781 KR
• Official Correspondent:
  • Leonardo Hur
  • 82-2-69285385-x
• US Agent:
  • Daniel Kamm
  • Kamm & Associates
  • 239 4171727
  • fda.help.now@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: #1005, 25 Seongsuil-ro 4-gil Seongdong-gu,; Seoul, 04781 KR
• Establishment Type: Manufacture Medical Device

• Registration Number: 3013133026
• FEI Number: 3013133026
• Name: DAIHAN Biomedical INC.
• Owner & Operator: ASTERASYS Co., Ltd.
• Contact Address: #1005, 25 Seongsuil-ro 4-gil Seongdong-gu; Seoul KR-NOTA 04781 KR
• Official Correspondent:
  • Leonardo Hur
  • 82-2-69285385-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 12916 Dupont Circle ; Tampa, FL 33626 US

FDA Filings

Device Company	Device	Date
PUH ASTERASYS Co., Ltd [ASTERASYS Co., Ltd.]	InBalance 300	2020-02-05