Dornier Medtech Systems G M B H

FDA Filings

This page includes the latest FDA filings for Dornier Medtech Systems 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: 9611388
• FEI Number: 3002806833
• Name: DORNIER MEDTECH SYSTEMS GMBH
• Owner & Operator: DORNIER MEDTECH SYSTEMS, GMBH
• Contact Address: ARGELSRIEDER FELD 7 --; WESSLING DE-NOTA D82234 DE
• Official Correspondent:
  • John - Hoffer
  • 001-770-5146163-x
• US Agent:
  • John Hoffer
  • DORNIER MEDTECH AMERICA, INC.
  • 770 5146163 0
  • 770 5146288
  • jhoffer@dornier.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ARGELSRIEDER FELD 7 ; WESSLING Bayern, D-82234 DE
• Establishment Type: Manufacture Medical Device

• Registration Number: 9611812
• FEI Number: 3002807538
• Name: DORNIER MEDTECH LASER GMBH
• Owner & Operator: DORNIER MEDTECH SYSTEMS, GMBH
• Contact Address: ARGELSRIEDER FELD 7 --; WESSLING DE-NOTA D82234 DE
• Official Correspondent:
  • John - Hoffer
  • 001-770-5146163-x
• US Agent:
  • John Hoffer
  • Dornier MedTech America
  • 770 5146163 0
  • jhoffer@dornier.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ARGELSRIEDER FELD 7 ; WESSLING Bayern, D-82234 DE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04049957006471 Dornier MedTech Systems GmbH	Dornier Delta III K1045938	2023-04-03
GUDID 04049957006464 Dornier MedTech Systems GmbH	Dornier Delta III K1045937	2023-04-03
GUDID 04049957005634 Dornier MedTech Systems GmbH	Dornier MedTech K1039061	2018-10-15
GUDID 04049957005566 Dornier MedTech Systems GmbH	Dornier MedTech K1041701	2018-10-15
GUDID 04049957005559 Dornier MedTech Systems GmbH	Dornier MedTech K1041700	2018-10-15
GUDID 04049957005429 Dornier MedTech Systems GmbH	Dornier MedTech K1039062	2018-10-15
GUDID 04049957004231 Dornier MedTech Systems GmbH	Dornier MedTech K1034310	2018-10-15
GUDID 04049957004224 Dornier MedTech Systems GmbH	Dornier MedTech K1034309	2018-10-15
GUDID 04049957004118 Dornier MedTech Systems GmbH	Dornier MedTech K1034269	2018-10-15
GUDID 04049957004095 Dornier MedTech Systems GmbH	Dornier MedTech K1034267	2018-10-15
GUDID 04049957003265 Dornier MedTech Systems GmbH	Dornier MedTech K1032810	2018-10-15
GUDID 04049957003135 Dornier MedTech Systems GmbH	Dornier MedTech K1032806	2018-10-15
GUDID 04049957000714 Dornier MedTech Systems GmbH	Dornier MedTech K1018869	2018-10-15
GUDID 04049957000578 Dornier MedTech Systems GmbH	Dornier MedTech K1029226	2018-10-15
GUDID 04049957000561 Dornier MedTech Systems GmbH	Dornier MedTech K1029225	2018-10-15
GUDID 04049957000554 Dornier MedTech Systems GmbH	Dornier MedTech K1028986	2018-10-15
GUDID 04049957000028 Dornier MedTech Systems GmbH	Dornier MedTech K1029396	2018-10-15
GUDID 04049957000011 Dornier MedTech Systems GmbH	Dornier MedTech K1025660	2018-10-15
PMN K083500 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Medilas D Family Lasers	2018-09-12
PMN K021724 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Medilas Fibertome and Skinpulse Laser	2018-09-12
PMN K180350 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Medilas H Solvo 35 Laser	2018-04-18
PMN K172084 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Delta III Lithotripter	2017-08-17
PMN K151485 | JAA DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Genesis	2015-10-30
PMN K151298 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Gemini XXP-HP	2015-10-30
PMN K133434 | JAA DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Genesis II	2015-10-30
PMN K132672 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Gemini 220 XP	2015-10-30
PMN K130729 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Gemini FPD	2015-10-30
PMN K110364 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Lite Beam 1470	2013-08-27
PMN K122768 | JAA DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Genesis	2013-06-21
PMN K121656 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Gemini	2013-06-21
PMN K130344 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Medilas H Uropulse Holmium Laser	2013-06-07
PMN K122159 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Medilas H Solvo Holmium Laser	2013-06-07
PMN K080959 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Dornier Medilas D 1064	2009-12-22
PMN P840008 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	MPL	2008-03-26
PMN P840008 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	MFL	2008-03-26
PMN P840008 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	HM4	2008-03-26
PMN P840008 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	HM3	2008-03-26
PMN P840008 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Compact Delta Lithotripter	2008-03-26
PMN K991183 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Lasertrode Fiber	2008-03-26
PMN K955019 | KQS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Urotract	2008-03-26
PMN K955019 | KQS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	OPUS	2008-03-26
PMN K070536 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Dornier Medilas D60 Laser	2008-03-26
PMN K070536 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Dornier Medilas D30 Laser	2008-03-26
PMN K070536 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Dornier Medilas D Urobeam	2008-03-26
PMN K070536 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Dornier Medilas D Multibeam	2008-03-26
PMN K070536 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Dornier Medilas D Litebeam	2008-03-26
PMN K070536 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Dornier Medilas D Litebeam +	2008-03-26
PMN K070536 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Dornier Medilas D FlexiPulse	2008-03-26
PMN K070536 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Diode Family of Lasers	2008-03-26
PMN K061455 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Medilas H20 Laser	2008-03-26
PMN K011873 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Lithotripter Doli S	2008-03-26
PMN K011873 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Lithotripter Doli S-XP	2008-03-26
PMN K011873 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Gemini	2008-03-26
PMN K011773 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Lithotripter 140 (Doli 140)	2008-03-26
PMN K002929 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Compact Sigma Lithotripter	2008-03-26
PMN K002929 | LNS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	Compact Alpha Lithotripter	2008-03-26
PMN P000048 | NBN DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	DORNIER EPOS ULTRA	2006-04-14
KQS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	OPUSII	2006-04-14
KQS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	OPUS	2006-04-14
KQS DORNIER MEDTECH SYSTEMS GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	DORNIER UROTRACT 1	2006-04-14
PMN K981718 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	MEDILAS H20 LASER	1986-12-17
PMN K981718 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	DORNIER DIODE LASER LIGHT GUIDE	1986-12-17
PMN K981718 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	100 LASER	1986-12-17
PMN K981718 | GEX DORNIER MEDTECH LASER GMBH [DORNIER MEDTECH SYSTEMS, GMBH]	, FIBERTOME 5060	1986-12-17

Related Finance Registrations

NCAGE Code	C4411	DORNIER MEDTECH SYSTEMS GMBH
CAGE Code	C4411	DORNIER MEDTECH SYSTEMS GMBH DMTS
S.A.M. Registration	C4411 [318165065]	DORNIER MEDTECH SYSTEMS GMBH DMTS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092840281	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	DORNIER DELTA III SN 0163 WITH ACCESSORIES HS CODE 90189084,94029000	4 CAS
202008265613	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL EQUIPMENT AND ACCESSORIES HS CODE 90221400	8 PKG
202008218028	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL EQUIPMENT AND ACCESSORIES HS CODE 90221400	8 PKG
2020081812728	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL EQUIPMENT AND ACCESSORIES HS CODE 90221400	8 PKG
2020080341928	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL EQUIPMENT AND ACCESSORIES HS CODE 90221400	8 PKG
2020070618859	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL EQUIPMENT AND ACCESSORIES HS CODE 90189084 90221400 94029000	9 PKG
2020062511690	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL EQUIPMENT AND ACCESSORIES HS CODE 90189084 94029000	8 PKG
2020061919391	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL EQUIPMENT AND ACCESSORIES HS CODE 90189084 94029000	8 PKG