Valukumpu Oy

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009496855
• FEI Number: 3009496855
• Name: VALUKUMPU OY
• Owner & Operator: Valukumpu Oy
• Contact Address: Raivaajantie 1 ; Joensuu FI-IS Ita-Suomen laani 80100 FI
• Official Correspondent:
  • Martti Alastalo
  • 358-400-634046-x
• US Agent:
  • Gary Mocnik
  • Gary S. Mocnik and Associates
  • 949 4330413
  • gmocnik@cox.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Raivaajantie 1 ; Joensuu Ita-Suomen laani, 80100 FI
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K163343 | HKY VALUKUMPU OY	ICare Home Probe	2019-12-10
PMN K063873 | HKY VALUKUMPU OY	TA01i: - iCare tonometer - iCare	2016-05-06
PMN K063873 | HKY VALUKUMPU OY	TA011/ic100: Icare ic100 tonometer	2016-05-06
PMN K063873 | HKX VALUKUMPU OY	TA01i: - iCare tonometer - iCare	2016-05-06
PMN K063873 | HKX VALUKUMPU OY	TA011/ic100: Icare ic100 tonometer	2016-05-06

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009125058	Anvers,Belgium -> Charleston, South Carolina	CRANE PARTS; VALVE KITS EX KN VAA 2417-0878-007.011 CONTACT DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS DESTINATION ATLANTA	1 PKG
2020090410912	Anvers,Belgium -> Charleston, South Carolina	CRANE PARTS; VALVE KITS EX KN VAA 2417-0878-007.011 CONTACT DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS DESTINATION ATLANTA	1 PKG
2020082526666	Anvers,Belgium -> Charleston, South Carolina	CRANE PARTS; VALVE KITS EX KN VAA 2417-0878-007.011 CONTACT DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS DESTINATION ATLANTA	1 PKG
2020082231301	Anvers,Belgium -> Charleston, South Carolina	CRANE PARTS; VALVE KITS EX KN VAA 2417-0878-007.011 CONTACT DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS DESTINATION ATLANTA	1 PKG
2020082130959	Anvers,Belgium -> Charleston, South Carolina	CRANE PARTS; VALVE KITS EX KN VAA 2417-0878-007.011 CONTACT DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS DESTINATION ATLANTA	1 PKG
2020081942144	Anvers,Belgium -> Charleston, South Carolina	CRANE PARTS; VALVE KITS EX KN VAA 2417-0878-007.011 CONTACT DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS DESTINATION ATLANTA	1 PKG
2020081839645	Anvers,Belgium -> Charleston, South Carolina	CRANE PARTS; VALVE KITS EX KN VAA 2417-0878-007.011 CONTACT DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS DESTINATION ATLANTA	1 PKG
2020081555318	Anvers,Belgium -> Charleston, South Carolina	CRANE PARTS; VALVE KITS EX KN VAA 2417-0878-007.011 CONTACT DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS DESTINATION ATLANTA	1 PKG