Gerresheimer Regensburg G M B H

FDA Filings

This page includes the latest FDA filings for Gerresheimer Regensburg 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 Number3007966578
FEI Number3007966578
NameJuan Lopez
Owner & OperatorGerresheimer Regensburg GmbH
Contact AddressKumpfmuehlerstrasse 2
Regensburg DE-BY Bayern 93047 DE
Official Correspondent
  • Paula Schmidt
  • 49-9431-6397649-57659
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address650 Highway 74 South
Peachtree City, GA 30269 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3008837296
FEI Number3008837296
NameGerresheimer Medical Plastic Systems Dongguan Co., Ltd.
Owner & OperatorGerresheimer Regensburg GmbH
Contact AddressKumpfmuehlerstrasse 2
Regensburg DE-BY Bayern 93047 DE
Official Correspondent
  • Paula Schmidt
  • 49-9431-6397649-57659
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressBuilding 5 - 6, Zone No. 4 ZhongHanQiao Industrial Park WangNiuDun Town
Dongguan City Guangdong, 523200 CN
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Juan Lopez [Gerresheimer Regensburg GmbH]
Softclix2009-10-23
Juan Lopez [Gerresheimer Regensburg GmbH]
Multiclix2009-10-23
Juan Lopez [Gerresheimer Regensburg GmbH]
FastClix2009-10-23
Gerresheimer Medical Plastic Systems Dongguan Co., Ltd. [Gerresheimer Regensburg GmbH]
Softclix2009-10-23
Gerresheimer Medical Plastic Systems Dongguan Co., Ltd. [Gerresheimer Regensburg GmbH]
Multiclix2009-10-23
Gerresheimer Medical Plastic Systems Dongguan Co., Ltd. [Gerresheimer Regensburg GmbH]
FastClix2009-10-23

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020063038332Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaPASTIC GRANULES HS-CODE 390740 HBL BANQBRE4296426 . . .6 PKG
2020052942569Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCYROLITE GS 90 NATUR12 PKG
201906271939Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyCHEST WITH ,OLD CUVETTE 6 CELL J200261 CAS
2018061461345Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyGRANULATE 165 PACKAGES PACKED ON 3 PALLETS HS CODE 390210 HBL265929150MUC165 PKG
2018061369199Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyGRANULATE 165 PACKAGES PACKED ON 3 PALLETS HS CODE 390210 HBL265929150MUC165 PKG
2018021547899Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaEQUIPMENT FOR CHASSIS TOOL HS 848071001 CHS
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