Thelios S P A

FDA Filings

This page includes the latest FDA filings for Thelios S P A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014159107
• FEI Number: 3014159107
• Name: N/A
• Owner & Operator: THELIOS S.P.A.
• Contact Address: ZONA INDUSTRIALE VILLANOVA SNC CAP (BL) ; Longarone IT-BL Belluno 32013 IT
• Official Correspondent:
  • Enrico Sanavia
  • 39-043-7777263-x
• US Agent:
  • N/A
  • N/A
  • 0
  • N/A
• Importing Logistics Registration:
  • Importer: Thelios USA Inc
  • Address: 3140 US 22 W ; Somerville, NJ 08876 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: N/A N/A; N/A, NA N/A US
• Establishment Type: Repack or Relabel Medical Device

• Registration Number: 3014168883
• FEI Number: 3014168883
• Name: THELIOS USA INC
• Owner & Operator: THELIOS S.P.A.
• Contact Address: ZONA INDUSTRIALE VILLANOVA SNC CAP (BL) ; Longarone IT-BL Belluno 32013 IT
• Official Correspondent:
  • Enrico Sanavia
  • 39-043-7777263-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3140 US 22 W ; Somerville, NJ 08876 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
HQZ THELIOS USA INC [THELIOS S.P.A.]	Celine	2017-11-29
HQZ N/A [THELIOS S.P.A.]	Celine	2017-11-29
HQY THELIOS USA INC [THELIOS S.P.A.]	Celine	2017-11-29
HQY N/A [THELIOS S.P.A.]	Celine	2017-11-29
HOI THELIOS USA INC [THELIOS S.P.A.]	Celine	2017-11-29
HOI N/A [THELIOS S.P.A.]	Celine	2017-11-29

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080352259	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PLASTIC CASES HS 420432	2 PKG
2020072917558	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	DISLAY	9 PKG
2020071670254	Genova,Italy -> New York, New York	PLASTIC CASES HS 420432	2 PKG
2020071335822	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	DISLAY	9 PKG
2020070252106	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	DISPLAY AND CASES	20 PKG
2020042240947	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	DISPLAY PL 10980 REF M315CMB03 M311CMB05	15 PKG
2020042240947	La Spezia,Italy -> New York/Newark Area, Newark, New Jersey	DISPLAY PL 10940 41 REF M315CMB03 M311CMB05	15 PKG
201804146525	Genova,Italy -> New York/Newark Area, Newark, New Jersey	ADVERTISING MATERIAL DISPLAY HS3926 44 21 6809 7009 4414	9 PCS
2018041110610	Genova,Italy -> New York/Newark Area, Newark, New Jersey	ADVERTISING MATERIAL DISPLAY HS3926 44 21 6809 7009 4414	9 PCS