Seebreath Ab

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006307105
• FEI Number: 3006307105
• Name: MedDev Manufacturing Sdn Bhd
• Owner & Operator: SeeBreath AB
• Contact Address: Birger Jarlsgatan 2 ; Stockholm SE-AB Stockholms lan [SE-01] 11434 SE
• Official Correspondent:
  • Anette Sjogren
  • 46-46-295358-x
• US Agent:
  • Mark Swanson
  • 763 2340727
  • mark@hmcg.biz
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No 115 Jalan Serunai, 1, Kawasan 3 ; Klang Selangor, 41200 MY
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3009754460
• FEI Number: 3009754460
• Name: SEEBREATH AB
• Owner & Operator: SeeBreath AB
• Contact Address: Birger Jarlsgatan 2 ; Stockholm SE-AB Stockholms lan [SE-01] 11434 SE
• Official Correspondent:
  • Anette Sjogren
  • 46-46-295358-x
• US Agent:
  • Mark Swanson
  • 763 2340727
  • mark@hmcg.biz
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Birger Jarlsgatan 2 ; Stockholm Stockholms lan [SE-01], 11434 SE
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K112840 | CCK SEEBREATH AB	CapnoDura Combi, CapnoDura Pedi	2012-08-10
PMN K112840 | CCK MedDev Manufacturing Sdn Bhd [SeeBreath AB]	CapnoDura Combi, CapnoDura Pedi	2012-08-10
PMN K112840 SEEBREATH AB	CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR	2012-07-13