Trulife

FDA Filings

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

FDA Registration(s)

• Registration Number: 8020869
• FEI Number: 5714
• Name: Jessica Niles
• Owner & Operator: Trulife
• Contact Address: Airton Road Tallaght; Dublin 24 IE-NOTA -- IE
• Official Correspondent:
  • Michelle Dempsey
  • 353-1-4511755-x
• US Agent:
  • Jessica Niles
  • TRULIFE, INC.
  • 360 6975656
  • 360 6974836
  • jniles@trulife.com
• Importing Logistics Registration:
  • Importer: Alimed
  • Address: 297 HIGH STREET ; Dedham, MA 02026 UNITED STATES
  • Importer Type: Distributor
• Importing Logistics Registration:
  • Importer: Trulife Jackson
  • Address: 2010 East High Street ; Jackson, MI 49202 UNITED STATES
  • Importer Type: Distributor
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 26284 Twelve Trees Lane NW Building 1; Poulsbo, WA 98370 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006979871
• FEI Number: 3006979871
• Name: Ed Dulay
• Owner & Operator: Trulife
• Contact Address: 41 Amos Road (Off Meadowhall Rd) ; Sheffield GB-SHF Sheffield S9 1BX GB
• Official Correspondent:
  • Sean M Jackson
  • 44-114-2428987-x
• US Agent:
  • Ed Dulay
  • TRULIFE, INC.
  • 360 5988934
  • edulay@trulife.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 26284 Twelve Trees Lane NW ; Poulsbo, WA 98370 US
• Establishment Type: Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
ITC Ed Dulay [Trulife]	Matrix composite strut	2017-03-23
NOJ Jessica Niles [Trulife]	Breastcare	2014-01-06
IQI Ed Dulay [Trulife]	Sure Step Medial	2008-04-01
IQI Ed Dulay [Trulife]	Sure Step Medial T	2008-04-01
IQI Ed Dulay [Trulife]	Matrix	2008-04-01
IQI Ed Dulay [Trulife]	Matrix SuperMax	2008-04-01
IQI Ed Dulay [Trulife]	Matrix Raw	2008-04-01
IQI Ed Dulay [Trulife]	Matrix Max	2008-04-01
IQI Ed Dulay [Trulife]	Matrix Max 2	2008-04-01
IMP Jessica Niles [Trulife]	Relax	2001-08-24
KCZ Jessica Niles [Trulife]	Breastcare Adhesive	2001-06-21
JZR Jessica Niles [Trulife]	Pressurecare	1997-09-26

Similar & Related FDA Registered Companies

• TRULIFE, INC.
• Trulife Jackson
• TRULIFE LTD.

Related Finance Registrations

NCAGE Code	48D77	TRULIFE
CAGE Code	48D77	TRULIFE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081276625	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL GEL PADS SILICONE PROSTHESIS	5 CTN
2019012534500	Shanghai ,China (Mainland) -> Tacoma, Washington	NYLON SPANDEX FABRIC	43 CTN
2019012433109	Shanghai ,China (Mainland) -> Tacoma, Washington	NYLON SPANDEX FABRIC	43 CTN
2018030153629	Kaohsiung,China (Taiwan) -> Los Angeles, California	ORTHOPEDIC APPLIANCES FDA REGISTRATION NO 20 13693 TRULIFE OWNER OPERATOR 3022549 TRULIF E PRODUCT CODE ITW REF REGULATION NO 21 CF P 890 3475 MEDICAL DEVICE NUMBER R060502 PRO DUCT LISTING CODE E439264 REGISTRATION NUMBE R 3004129296 KAO CHEN	46 CTN
2018022624196	Laem Chabang,Thailand -> Tacoma, Washington	LACE COMPOSITION	8 CTN
2018010349781	Taipei,China (Taiwan) -> Los Angeles, California	SILICONE RUBBER	16 PAL