Lre Medical G M B H

FDA Filings

This page includes the latest FDA filings for Lre Medical 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: 3003366417
• FEI Number: 3003366417
• Name: Alan Schwartz
• Owner & Operator: LRE MEDICAL GMBH
• Contact Address: HOFER STRASSE 5 --; NOERDLINGEN DE-BY Bayern 86720 DE
• Official Correspondent:
  • Johann Meyr
  • 49-9081-800-190
• US Agent:
  • Alan Schwartz
  • mdi Consultants, Inc.
  • 516 4829001
  • 516 4820186
  • alan@mdiconsultants.com
• Importing Logistics Registration:
  • Importer: Astute Medical, Inc.
  • Address: 3550 General Atomics Court ; San Diego, CA 92121 UNITED STATES
  • Email Address: info@astutemedical.com
  • Phone: 1 858 5007000
  • FAX: 1 858 8820449
• Importing Logistics Registration:
  • Importer: Cambridge Sensors USA LLC
  • Address: 10051 Bode St. Plainfield IL ; Plainfield, 60585 UNITED KINGDOM
  • Subdivision: GB-CAM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 55 Northern Blvd., Suite 200 Great Neck, NY 11021; Great Neck, NY 11021 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K183597 | OOI Alan Schwartz [LRE MEDICAL GMBH]	QIAstat-dx? Analyzer 1.0	2019-05-22
PMN K171482 | PIG Alan Schwartz [LRE MEDICAL GMBH]	Astute140	2019-03-08
PMN K151048 | IZQ Alan Schwartz [LRE MEDICAL GMBH]	CT ExpresTM 3D Contrast Media Delivery System	2017-11-02
PMN K112177 | KHO Alan Schwartz [LRE MEDICAL GMBH]	Sofia Analyzer Quidel	2011-11-07
PMN K112177 | GNX Alan Schwartz [LRE MEDICAL GMBH]	Sofia Analyzer Quidel	2011-11-07
PMN K060280 | LJX Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | KQO Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | JMT Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | JMA Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | JJQ Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | JJB Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | JIR Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | JIO Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | JIN Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | JIL Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | CEN Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K060280 | CDM Alan Schwartz [LRE MEDICAL GMBH]	iChem100	2011-10-07
PMN K083273 | NBW Alan Schwartz [LRE MEDICAL GMBH]	Microdot xtra	2010-06-22
PMN K083273 | LFR Alan Schwartz [LRE MEDICAL GMBH]	Microdot xtra	2010-06-22
PMN K083273 | JJX Alan Schwartz [LRE MEDICAL GMBH]	Microdot xtra	2010-06-22
PMN K080227 | MRZ Alan Schwartz [LRE MEDICAL GMBH]	Accu Chek 360	2009-10-12
PMN K062395 | NBW Alan Schwartz [LRE MEDICAL GMBH]	Accu Chek Smart Pix	2009-10-12
PMN K062395 | LZG Alan Schwartz [LRE MEDICAL GMBH]	Accu Chek Smart Pix	2009-10-12
PMN K062395 | JQP Alan Schwartz [LRE MEDICAL GMBH]	Accu Chek Smart Pix	2009-10-12
PMN K070524 | NBW Alan Schwartz [LRE MEDICAL GMBH]	Microdot Blood Glucos Monitoring Sy	2007-12-12
PMN K070524 | LFR Alan Schwartz [LRE MEDICAL GMBH]	Microdot Blood Glucos Monitoring Sy	2007-12-12
PMN K070524 | JJX Alan Schwartz [LRE MEDICAL GMBH]	Microdot Blood Glucos Monitoring Sy	2007-12-12
PMN K973547 | MMI Alan Schwartz [LRE MEDICAL GMBH]	TRIAGE METER	2006-05-08
PMN K973547 | KHO Alan Schwartz [LRE MEDICAL GMBH]	TRIAGE METER	2006-05-08
PMN K973547 | JHX Alan Schwartz [LRE MEDICAL GMBH]	TRIAGE METER	2006-05-08
PMN K973547 | DDR Alan Schwartz [LRE MEDICAL GMBH]	TRIAGE METER	2006-05-08
PMN K051376 | NBW Alan Schwartz [LRE MEDICAL GMBH]	UCHECK	2006-05-08
PMN K051376 | NBW Alan Schwartz [LRE MEDICAL GMBH]	ACCUCHECK	2006-05-08
PMN K051376 | NBW Alan Schwartz [LRE MEDICAL GMBH]	ACCUCHECK INSTAND PLUS DUAL TESTING	2006-05-08
PMN K051376 | CHH Alan Schwartz [LRE MEDICAL GMBH]	UCHECK	2006-05-08
PMN K051376 | CHH Alan Schwartz [LRE MEDICAL GMBH]	ACCUCHECK	2006-05-08
PMN K051376 | CHH Alan Schwartz [LRE MEDICAL GMBH]	ACCUCHECK INSTAND PLUS DUAL TESTING	2006-05-08
PMN K051376 | CGA Alan Schwartz [LRE MEDICAL GMBH]	UCHECK	2006-05-08
PMN K051376 | CGA Alan Schwartz [LRE MEDICAL GMBH]	ACCUCHECK	2006-05-08
PMN K051376 | CGA Alan Schwartz [LRE MEDICAL GMBH]	ACCUCHECK INSTAND PLUS DUAL TESTING	2006-05-08

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009115815	Stadersand,Federal Republic of Germany -> Los Angeles, California	MEDICAL EQUIPMENTHS CODE90181990	1 PKG
2020082718744	Stadersand,Federal Republic of Germany -> Los Angeles, California	MEDICAL EQUIPMENTHS CODE90181990	1 PKG
202007167210	Stadersand,Federal Republic of Germany -> Los Angeles, California	MEDICAL DEVICESHS CODE90181990	5 CTN
2020070719068	Stadersand,Federal Republic of Germany -> Los Angeles, California	MEDICAL DEVICESHS CODE90181990	5 CTN
202006303383	Stadersand,Federal Republic of Germany -> Los Angeles, California	MEDICAL DEVICES	5 CTN
202006263311	Stadersand,Federal Republic of Germany -> Los Angeles, California	MEDICAL DEVICES	5 CTN
202006254690	Stadersand,Federal Republic of Germany -> Los Angeles, California	MEDICAL DEVICES	5 CTN
202006245294	Stadersand,Federal Republic of Germany -> Los Angeles, California	MEDICAL DEVICES	5 CTN