Aesku Systems G M B H Co Kg

FDA Filings

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

FDA Registration(s)
Registration Number3007510296
FEI Number3007510296
NameAESKU.SYSTEMS GMBH&CO.KG.
Owner & OperatorAesku.Systems GmbH & Co. KG
Contact AddressAESKU.SYSTEMS GmbH & Co. KG Mikroforum Ring 3
Wendelsheim DE-RP Rheinland-Pfalz 55234 DE
Official Correspondent
  • Torsten Matthias
  • 49-673-49622-0
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressAESKU.SYSTEMS GmbH&Co.KG. Mikroforum Ring 3
Wendelsheim Rheinland-Pfalz, 55234 DE
Establishment Type
  • Foreign Private Label Distributor
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Aesku.Systems GmbH & Co. KG
 HELIOS IOS-10002020-03-10
Aesku.Systems GmbH & Co. KG
 HELMED HEL-10002020-03-10
Aesku.Systems GmbH & Co. KG
 HELIOS IOS-10002020-03-03
Aesku.Systems GmbH & Co. KG
 HELMED HEL-10002020-03-03
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
HELIOS Automated IFA System2016-09-15
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
HELIOS Automated IFA System2016-09-15
AESKU. SYSTEMS GMBH & CO. KG
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM2016-07-28
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
HERA2015-08-10
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
AESKU.LAB2015-08-10
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
SQII2014-06-02
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
HELMED IFA2014-06-02
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
HELMED HTC2014-06-02
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
HELMED ELISA2014-06-02
AESKU.SYSTEMS GMBH&CO.KG. [Aesku.Systems GmbH & Co. KG]
HELMED BLOT2014-06-02

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