Corflex

FDA Filings

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

Corflex holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Corflex Caribe

FDA Registration(s)

• Registration Number: 3010621943
• FEI Number: 3010621943
• Name: Corflex Caribe
• Owner & Operator: CORFLEX
• Contact Address: 669 EAST INDUSTRIAL PARK DRIVE; Manchester NH 03109 US
• Official Correspondent:
  • PAUL - LORENZETTI
  • 1-603-6233344-x
• US Agent:
  • Richard LaRochelle
  • Corflex
  • 603 6233344
  • Richard@corflex.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Zona Franca Industrial de San Isidro antigua nave MFI-2; Santo Domingo Este Santo Domingo, 15801 DO
• Establishment Type: Manufacture Medical Device

• Registration Number: 1218997
• FEI Number: 1218997
• Name: CORFLEX
• Owner & Operator: CORFLEX
• Contact Address: 669 EAST INDUSTRIAL PARK DRIVE; Manchester NH 03109 US
• Official Correspondent:
  • PAUL - LORENZETTI
  • 1-603-6233344-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 669 EAST INDUSTRIAL PARK DRIVE; MANCHESTER, NH 03109 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
FZF CORFLEX	CRYO PNEUMATIC	2017-11-10
ITQ Corflex Caribe [CORFLEX]	joint, knee, external brace	2013-12-16
ITQ CORFLEX	joint, knee, external brace	2013-12-16
IQE Corflex Caribe [CORFLEX]	orthosis, lumbar	2013-12-16
IQE CORFLEX	orthosis, lumbar	2013-12-16
FSD CORFLEX	BINDER, ABDOMINAL	2013-12-16
KMO Corflex Caribe [CORFLEX]	BINDER, ELASTIC	2013-12-12
IME Corflex Caribe [CORFLEX]	Hot / Cold Pack	2013-02-13
IME CORFLEX	Hot / Cold Pack	2013-02-13
KQZ Corflex Caribe [CORFLEX]	NONINVASIVE TRACTION COMPONENT	2001-10-12
KQZ CORFLEX	NONINVASIVE TRACTION COMPONENT	2001-10-12
ISS Corflex Caribe [CORFLEX]	EXTERNAL LIMB PROSTHETIC COMPONENT	2001-10-12
ISS CORFLEX	EXTERNAL LIMB PROSTHETIC COMPONENT	2001-10-12
IQI Corflex Caribe [CORFLEX]	LIMB ORTHOSIS	2001-10-12
IQI CORFLEX	LIMB ORTHOSIS	2001-10-12
ILZ CORFLEX	TRACTION ACCESORY	2001-10-12

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092381073	Rio Jaina,Dominican Republic -> New York, New York	ORTHOPEDICS COMPONENTS .	453 CAS
2020091581616	Rio Jaina,Dominican Republic -> New York, New York	ORTHOPEDICS COMPONENT	264 CAS
20200909129281	Rio Jaina,Dominican Republic -> New York, New York	ORTHOPEDICS COMPONENT	338 CAS
2020090291762	Rio Jaina,Dominican Republic -> New York, New York	ORTHOPEDICS COMPONENT	387 CAS
2020082665650	Rio Jaina,Dominican Republic -> New York, New York	ORTHOPEDICS COMPONENT	248 CAS
2020082084303	Rio Jaina,Dominican Republic -> New York, New York	ORTHOPEDICS COMPONENT	599 CAS
2020081982200	Rio Jaina,Dominican Republic -> New York, New York	ORTHOPEDICS COMPONENT	599 CAS
2020080774990	Rio Jaina,Dominican Republic -> New York, New York	ORTHOPEDICS COMPONENT .	332 CAS