Mibetec G M B H

FDA Filings

This page includes the latest FDA filings for Mibetec G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015733772
• FEI Number: 3015733772
• Name: MIBETEC GMBH
• Owner & Operator: MibeTec GmbH
• Contact Address: Munchener Strasse 15 ; Sandersdorf-Brehna DE-ST Sachsen-Anhalt 06796 DE
• Official Correspondent:
  • Kenneth K Kleinhenz
  • 049-619-2449573-x
• US Agent:
  • Kenneth Kleinhenz
  • QSR Consulting
  • 619 2449573
  • kleinhenz64@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Munchener Strasse 15 ; Sandersdorf-Brehna Sachsen-Anhalt, 06796 DE
• Establishment Type: Manufacture Medical Device

• Registration Number: 3015633277
• FEI Number: 3015633277
• Name: MIBETEC U.S.
• Owner & Operator: MibeTec GmbH
• Contact Address: Munchener Strasse 15 ; Sandersdorf-Brehna DE-ST Sachsen-Anhalt 06796 DE
• Official Correspondent:
  • Kenneth K Kleinhenz
  • 049-619-2449573-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 801 Barton Springs Rd Floor 7 - Office 121; Austin, TX 78704 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K220514 MibeTec, GmbH	Bite Away Neo	2022-06-23
GUDID 04260624040295 MibeTec GmbH	bite away VI00545	2020-02-14
PMN K160943 | IRT MIBETEC U.S. [MibeTec GmbH]	Bite Away	2019-07-17
PMN K160943 | IRT MIBETEC GMBH	Bite Away	2019-07-17