Dre Inc

FDA Filings

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

Dre Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• SHU-CHEN CHENG
• Michael van der Woude
• Jerry Andexler
• David Lennarz
• BRUSAFERRI & C. SRL

FDA Registration(s)

• Registration Number: 1000122786
• FEI Number: 1000122786
• Name: DRE Medical Group Inc.
• Owner & Operator: DRE, INC DBA Avante Health Solutions
• Contact Address: 2601 Stanley Gault PKWY Suite 101; Louisville KY 40223 US
• Official Correspondent:
  • Jerry - Andexler
  • x-502-2444444-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2601 Stanley Gault PKWY ; Louisville, KY 40223 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K150901 | HGM DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	AVANTE COMPACT PLUS	2016-08-23
PMN K150901 | HGM DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	AVANTE COMPACT FM FETAL MONITOR	2016-08-23
PMN K002257 | GEI DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	AVANTE MONOPOLAR HANDSWITCHING PENCIL	2016-02-09
PMN K971749 | BTA DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	DM-530	2015-09-15
PMN K932494 | BTA DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	AVANTE DM-660	2015-09-15
PMN K061102 | BSZ DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	INTEGRA SPII	2007-12-28
PMN K061102 | BSZ DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	INTEGRA SP VSO2	2007-12-28
PMN K061102 | BSZ DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	INTEGRA SP I	2007-12-28
PMN K061102 | BSZ DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	INTEGRA SL	2007-12-28
PMN K061102 | BSZ DRE Medical Group Inc. [DRE, INC DBA Avante Health Solutions]	INTEGRA SL3	2007-12-28

Similar & Related FDA Registered Companies

• Dreem Inc.
• DRE MEDICAL, INC.
• DREAMGARD, INC.
• DREW SCIENTIFIC, INC.
• DRESSER ARGUS, INC.
• Dressel Welding Supply, Inc.
• Dreumex USA, Inc.
• DREAM FACTORY INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009106654	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MOUNTING PLATE FOR WAVELINE SERIALS	76 CTN
2020090414416	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MOUNTING PLATE FOR WAVELINE SERIALS	76 CTN
2020082417871	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	ORTHOPEDIC TRACTION	3 CTN
2020080821552	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	OPERATING TABLE	2 CTN
202008032885	Yantian,China (Mainland) -> Norfolk, Virginia	ROLLING STAND FOR WAVELINE SERIALS	250 CTN
2020072718375	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	OPERATING TABLE	8 CTN
2020071539807	Ningpo ,China (Mainland) -> Los Angeles, California	TROLLEY	20 CTN
2020062039564	Ningpo ,China (Mainland) -> Long Beach, California	TROLLEY	25 CTN