Enterix Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 1226769
• FEI Number: 3003224146
• Name: ENTERIX INC.
• Owner & Operator: CLINICAL GENOMICS
• Contact Address: 236 Fernwood Avenue ; Edison NJ 08837 US
• Official Correspondent:
  • Michele Houldsworth
  • 1-908-3008673-0
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 236 Fernwood Ave ; EDISON, NJ 08837 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 30850093003317 ENTERIX INC.	InSure® ONE™	2018-07-06
GUDID 10850093003085 ENTERIX INC.	InSure FIT	2018-07-06
GUDID 00850093003354 ENTERIX INC.	InSure® ONE™ 90035.01	2018-07-06
GUDID 00850093003347 ENTERIX INC.	InSure® ONE™	2018-07-06
GUDID 00850093003309 ENTERIX INC.	InSure® ONE™ 90002.01	2018-07-06
GUDID 00850093003293 ENTERIX INC.	InSure® ONE™ 14103.01	2018-07-06
GUDID 00850093003286 ENTERIX INC.	InSure® ONE™ 11018.01	2018-07-06
GUDID 00850093003279 ENTERIX INC.	InSure® ONE™ 90030.01	2018-07-06
GUDID 00850093003231 ENTERIX INC.	InSure® ONE™ 80025.01	2018-07-06
GUDID 00850093003187 ENTERIX INC.	InSure FIT 90002	2018-07-06
GUDID 00850093003095 ENTERIX INC.	InSure FIT 14103	2018-07-06
GUDID 00850093003071 ENTERIX INC.	InSure FIT 11018	2018-07-06
GUDID 00850093003064 ENTERIX INC.	InSure FIT 15022	2018-07-06
GUDID 00850093003040 ENTERIX INC.	InSure FIT	2018-07-06
GUDID 00850093003033 ENTERIX INC.	InSure FIT 16800	2018-07-06
GUDID 00850093003019 ENTERIX INC.	InSure FIT 80025	2018-07-06
PMN K170548 | KHE ENTERIX INC. [CLINICAL GENOMICS]	InSure ONE	2017-11-16
PMN K170548 Enterix Inc.	InSure ONE	2017-10-05
PMN K101831 | OSL ENTERIX INC. [CLINICAL GENOMICS]	InSure FIT FOBT Controls	2014-09-05
PMN K002457 | KHE ENTERIX INC. [CLINICAL GENOMICS]	MULTIPLE OCCULT BLOOD TEST	2006-05-19
PMN K060930 ENTERIX INC.	INSURE II	2006-05-04
PMN K002457 ENTERIX INC.	!NSURE FECAL OCCULT BLOOD TEST	2001-01-12

Related Finance Registrations

SEC

0001157442

ENTERIX INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091216774	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	INSURE ONE BRUSH KIT HS CODE:96039090 . . . . .	834 CTN
2020073127107	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	98 CTNS DIAGNOSTIC TEST CARDS PACKED ON 2 PALLETS HS CODE: 38220003	98 CTN
202007148512	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	INSURE ONE BRUSH KIT HS CODE:96039090 . . . . .	834 CTN
2020071015058	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	INSURE ONE BRUSH KIT HS CODE:96039090 . . . . .	834 CTN
2020070125542	Yantian,China (Mainland) -> New York, New York	INSURE ONE BRUSH KIT HS CODE:96039090 . . . . .	834 CTN
2020062067554	Yantian,China (Mainland) -> New York, New York	INSURE ONE BRUSH KIT HS CODE:96039090 . . . . .	834 CTN
202005297737	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	INSURE ONE BRUSH KIT HS CODE: 96039090 . . . . .	834 CTN
2020051519750	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	INSURE TEST CARDS PACKED ON 1 PALLET HS CODE: 38220003	51 CTN