Ondal Medical Systems G M B H

FDA Filings

This page includes the latest FDA filings for Ondal Medical 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: 3012272052
• FEI Number: 3012272052
• Name: ONDAL MEDICAL SYSTEMS GMBH
• Owner & Operator: Ondal Medical Systems GmbH
• Contact Address: Wellastr. 6 ; Huenfeld DE-HE Hessen 36088 DE
• Official Correspondent:
  • Klaus Steger
  • 49-665-281354-x
• US Agent:
  • Christopher Walters
  • Ondal Medical Systems of America Inc.
  • 804 5321444
  • 804 5321494
  • walters.chris@ondal.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Wellastr. 6 ; Huenfeld Hessen, 36088 DE
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04061591001292 Ondal Medical Systems GmbH	Independant	2025-08-25
GUDID 04061591001322 Ondal Medical Systems GmbH	NuCart	2025-03-11
GUDID 04061591000851 Ondal Medical Systems GmbH	MCP Monitor Carrier Program / VALiA Display	2024-06-24
GUDID 04061591000844 Ondal Medical Systems GmbH	MCP Monitor Carrier Program / VALiA Display	2024-06-24
GUDID 04061591000578 Ondal Medical Systems GmbH	Zimmer Surgical Light	2020-12-14
GUDID 04061591000387 Ondal Medical Systems GmbH	Zubehoere	2020-09-08
GUDID 04061591000356 Ondal Medical Systems GmbH	CEMOR	2020-09-08
GUDID 04061591000349 Ondal Medical Systems GmbH	Medi Konsolenrohr	2020-09-08
GUDID 04061591000332 Ondal Medical Systems GmbH	Medilift	2020-09-08
GUDID 04061591000325 Ondal Medical Systems GmbH	Medilift	2020-09-08
GUDID 04061591000318 Ondal Medical Systems GmbH	MediBoom	2020-09-08
GUDID 04061591000295 Ondal Medical Systems GmbH	Valia	2020-09-08
GUDID 04061591000288 Ondal Medical Systems GmbH	Valia	2020-09-08
GUDID 04061591000264 Ondal Medical Systems GmbH	SpacePort	2020-09-08
GUDID 04061591000257 Ondal Medical Systems GmbH	VarioView	2020-09-08
GUDID 04061591000240 Ondal Medical Systems GmbH	CEMOR	2020-09-08
GUDID 04061591000202 Ondal Medical Systems GmbH	Versorgungskonsole	2020-09-08
GUDID 04061591000127 Ondal Medical Systems GmbH	Zentralachse	2020-09-08
GUDID 04061591000110 Ondal Medical Systems GmbH	OndaSpace	2020-09-08
GUDID 04061591000103 Ondal Medical Systems GmbH	Acrobat	2020-09-08
GUDID 04061591000080 Ondal Medical Systems GmbH	Deckenbefestigung	2020-09-08
GUDID 04061591000073 Ondal Medical Systems GmbH	Deckenbefestigung	2020-09-08
GUDID 04061591000066 Ondal Medical Systems GmbH	Deckenbefestigung	2020-09-08
GUDID 04061591000042 Ondal Medical Systems GmbH	Wandbefestigung	2020-09-08
GUDID 04061591000028 Ondal Medical Systems GmbH	Acrobat	2020-09-08
GUDID 04061591000004 Ondal Medical Systems GmbH	Acrobat	2020-09-08
BRY ONDAL MEDICAL SYSTEMS GMBH	M6-Mediboom System	2017-10-27
FQO ONDAL MEDICAL SYSTEMS GMBH	Monitor Carrier System CEMOR, CEMOR Smart, VarioView, VarioView 32	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Medium Duty Suspension VaLia S	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Medium Duty Suspension Hybrid Central Axis	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Medium Duty Suspension Central Axis	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Medium Duty Suspension ACROBAT 3000, ONDASPACE, SPACEPORT	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Light Duty Suspension VaLia L21, MD21, MD21+, LCH17	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Light Duty Suspension ACROBAT 2000, ACROBAT SWING	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Heavy Duty Suspension MediLift	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Heavy Duty Suspension MediBoom	2016-07-28
FQO ONDAL MEDICAL SYSTEMS GMBH	Ceiling Mounted Supply Unit Service Head M6	2016-07-28
FOX ONDAL MEDICAL SYSTEMS GMBH	INFUSION RACK	2016-07-28
FOX ONDAL MEDICAL SYSTEMS GMBH	INFUSION CROSS STRAIGHT	2016-07-28
FOX ONDAL MEDICAL SYSTEMS GMBH	INFUSION CROSS BEND	2016-07-28

Related Finance Registrations

NCAGE Code

DP220

ONDAL MEDICAL SYSTEMS GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092341002	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	MEDICAL EQUIPMENT HS CODE 3926 4821 7318 7326 7610 8504 . AMS HBL SHKK 276939244185	15 PCS
2020092233905	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	MEDICAL EQUIPMENT AMS HBL SHKK 276939243720	15 PKG
2020092158366	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	MEDICAL EQUIPMENT HS CODE 3926 4821 7318 7326 7610 8504 . AMS HBL SHKK 276939244185	15 PCS
202009171028	Stadersand,Federal Republic of Germany -> Houston, Texas	SAFETY SEGMENT MADE OF STEEL	16 PKG
202009171029	Stadersand,Federal Republic of Germany -> Houston, Texas	MEDICAL EQUIPMENT	8 PKG
202009171026	Stadersand,Federal Republic of Germany -> Houston, Texas	MEDICAL EQUIPMENT	4 PKG
202009171025	Stadersand,Federal Republic of Germany -> Houston, Texas	MEDICAL EQUIPMENT	2 PKG
202009171006	Stadersand,Federal Republic of Germany -> Houston, Texas	SUPPORT ARMS FOR MEDICAL DEVICES	8 PKG