Edward Allen

FDA Filings

This page includes the latest FDA filings for Edward Allen. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010155673
• FEI Number: 3010155673
• Name: Edward Allen
• Owner & Operator: Technochemia
• Contact Address: Fabryczna 3 ; Grojec PL-MZ Mazowieckie 05-600 PL
• Official Correspondent:
  • Adam Sztaba
  • 048-71-3818180-x
• US Agent:
  • Edward Allen
  • SteriPack USA Limited
  • 863 6482333 113
  • 863 6482999
  • e.allen@steripackgroup.com
• Importing Logistics Registration:
  • Importer: neoSurgical Inc.
  • Address: 820 East Terra Cotta Ave Ste. 149 ; Crystal Lake, IL 60014 UNITED STATES
  • Email Address: jimk@neosurgical.com
  • Phone: 1 815 8936153
  • Importer Type: US Authorized Representative
• Importing Logistics Registration:
  • Importer: SteriPack USA (Limited) LLC
  • Address: 4255 South Pipkin Road ; Lakeland, FL 33811 UNITED STATES
  • Email Address: e.allen@steripackgroup.com
  • Phone: 1 863 6482333 113
  • FAX: 1 863 6482999
  • Importer Type: AGENT
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4255 S PIPKIN RD ; LAKELAND, FL 33811 US
• Establishment Type: Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose Hasson 8/10 Port Closure Kit (US)	2015-01-12
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose Hasson 10/12 Port Closure Kit (US)	2015-01-12
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose AnchorGuide XL Port Closure Kit (US)	2015-01-12
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose AnchorGuide Regular Port Closure Kit X2 (US)	2015-01-12
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose AnchorGuide Regular Port Closure Kit (US)	2015-01-12
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose AnchorGuide 8/15 Port Closure Kit (1 Port) (US)	2015-01-12
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose AnchorGuide 5/15 Port Closure Kit (2 Ports) (US)	2015-01-12
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose AnchorGuide 5/12 Port Closure Kit (1 Port) (US)	2015-01-12
PMN K142903 | GCJ Edward Allen [Technochemia]	neoClose 4 AutoAnchor Pack (US)	2015-01-12
GDF Edward Allen [Technochemia]	neoClose AnchorGuide	2014-01-30
PMN K123280 | GCJ Edward Allen [Technochemia]	neoClose Universal	2013-06-05
PMN K123280 | GCJ Edward Allen [Technochemia]	neoClose Hasson	2013-06-05

Similar & Related FDA Registered Companies

• SteriPack USA Limited
• SteriPack USA (Limited) LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082413521	Tsingtao,China (Mainland) -> New York/Newark Area, Newark, New Jersey	HORIZONTAL MIXER	1 CTN
2019060551163	Bremerhaven,Federal Republic of Germany -> Baltimore, Maryland	HOUSEHOLD GOODS	9 BOX