Haselmeier G M B H

FDA Filings

This page includes the latest FDA filings for Haselmeier G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Haselmeier G M B H holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Haselmeier s.r.o.

FDA Registration(s)

• Registration Number: 1000288260
• FEI Number: 1000288260
• Name: Bonnie McIsaac
• Owner & Operator: HASELMEIER GMBH
• Contact Address: 48 VAIHINGER STRASSE --; STUTTGART DE-BW Baden-Wurttemberg D-70567 DE
• US Agent:
  • Bonnie McIsaac
  • HASELMEIER
  • 978 2523700
  • 978 7103207
  • B.McIsaac@haselmeier.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 126 John Street Suite 11; Lowell, MA 01852 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3008727519
• FEI Number: 3008727519
• Name: Haselmeier s.r.o.
• Owner & Operator: HASELMEIER GMBH
• Contact Address: 48 VAIHINGER STRASSE --; STUTTGART DE-BW Baden-Wurttemberg D-70567 DE
• US Agent:
  • Bonnie McIsaac
  • HASELMEIER GMBH
  • 978 2523700
  • 978 7103207
  • b.mcisaac@haselmeier.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Dnesice 277 ; Dnesice Plzen-sever, 334 43 CZ
• Establishment Type: Manufacture Medical Device

• Registration Number: 3007193283
• FEI Number: 3007193283
• Name: Bonnie McIsaac
• Owner & Operator: HASELMEIER GMBH
• Contact Address: 48 VAIHINGER STRASSE --; STUTTGART DE-BW Baden-Wurttemberg D-70567 DE
• US Agent:
  • Bonnie McIsaac
  • HASELMEIER INC
  • 978 2523700
  • 978 7103207
  • b.mcisaac@haselmeier.com
• Importing Logistics Registration:
  • Importer: Haselmeier, Inc.
  • Address: 517 Benfield Road, Suite 301 ; Severna Park, MD 21146 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 126 John Street Suite 11; Lowell, MA 01852 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K083457 HASELMEIER GMBH	TACTIPEN	2009-02-13
PMN K082616 HASELMEIER GMBH	HASELMEIER PEN 8	2008-09-26
PMN K070100 | FMF Haselmeier s.r.o. [HASELMEIER GMBH]	i-pen	2007-12-17
PMN K070100 | FMF Haselmeier s.r.o. [HASELMEIER GMBH]	i-pen2	2007-12-17
PMN K070100 | FMF Haselmeier s.r.o. [HASELMEIER GMBH]	Penlet	2007-12-17
PMN K070100 | FMF Haselmeier s.r.o. [HASELMEIER GMBH]	Axis-D disposable pen	2007-12-17
PMN K070100 | FMF Bonnie McIsaac [HASELMEIER GMBH]	i-pen	2007-12-17
PMN K070100 | FMF Bonnie McIsaac [HASELMEIER GMBH]	i-pen	2007-12-17
PMN K070100 | FMF Bonnie McIsaac [HASELMEIER GMBH]	i-pen2	2007-12-17
PMN K070100 | FMF Bonnie McIsaac [HASELMEIER GMBH]	i-pen2	2007-12-17
PMN K070100 | FMF Bonnie McIsaac [HASELMEIER GMBH]	Penlet	2007-12-17
PMN K070100 | FMF Bonnie McIsaac [HASELMEIER GMBH]	Penlet	2007-12-17
PMN K070100 | FMF Bonnie McIsaac [HASELMEIER GMBH]	Axis-D disposable pen	2007-12-17
PMN K070100 | FMF Bonnie McIsaac [HASELMEIER GMBH]	Axis-D disposable pen	2007-12-17