Loewenstein Medical Technology

FDA Filings

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

FDA Registration(s)

• Registration Number: 1000537145
• FEI Number: 1000537145
• Name: Loewenstein Medical Technology GMBH + CO. KG
• Owner & Operator: Loewenstein Medical Technology
• Contact Address: KRONSAALSWEG 40 --; HAMBURG DE-HH Hamburg 22525 DE
• Official Correspondent:
  • Thomas M Weber
  • 49-40-54702-0
• US Agent:
  • Thomas
  • Weber
  • 786 3014159
  • thomas.weber@lm-americas.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: KRONSAALSWEG 40 ; HAMBURG Hamburg, 22525 DE
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K112167 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	SOYALA SilkGel Full Face Mask	2012-01-05
PMN K112167 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	JOYCE SILKGEL FFM VENTED	2012-01-05
PMN K112167 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	EasyFit SilkGel Full Face Mask	2012-01-05
PMN K110884 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	JOYCE SILKGEL NM VENTED	2011-10-26
PMN K110884 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	EasyFit SilkGel Nasal Mask	2011-10-26
PMN K102515 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	NP15	2011-03-25
PMN K081014 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	SOYALA Gel vented	2008-05-15
PMN K081014 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	JOYCE NM GEL VENTED	2008-05-15
PMN K081014 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	EasyFit, Gel	2008-05-15
PMN K073673 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	SOYALA Full Face Mask Gel vented	2008-04-11
PMN K073673 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	JOYCE FFM GEL VENTED	2008-04-11
PMN K073673 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	EasyFit Full Face Mask, Gel	2008-04-11
PMN K070193 | DQA Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	smartOx	2007-11-23
PMN K061653 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	SOYALA Full Face Mask	2007-11-19
PMN K061653 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	JOYCE FULL FACE VENTED	2007-11-19
PMN K061653 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	JOYCE FULL FACE VENTED 40 HPA	2007-11-19
PMN K061653 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	EasyFit Full Face Mask, Silicone	2007-11-19
PMN K060405 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	SOYALA	2007-11-19
PMN K060405 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	EasyFit Silicone	2007-11-19
PMN K013738 | BZD Loewenstein Medical Technology GMBH + CO. KG [Loewenstein Medical Technology]	SOMNOplus	2007-11-19