Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025772870

FEI Number

3025772870

Entity Name

ENTERAL ACCESS TECHNOLOGIES, LTD.

City/State/Country

Caerwys Flintshire, GB

Establishment Address

Water Street, Caerwys Flintshire CH7 5AT, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Enteral Access Technologies, Ltd. (Owner Number: 10087023)

Owner / Operator Contact Address

Water Street, Caerwys, GB-FLN CH7 5AT, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212316

PMA Number

N/A

All Registered Proprietary Names

DoubleCHEK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2023-01-03

Official Correspondent

George Gallagher

US Agent Details

Michael Shaughnessy Business: Enteral Access Technologies, Inc. Email: mike@enteralaccesstech.com Phone: (847) 6829951

Related Public Records

Same Entity

Enteral Access Technologies, Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

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2528981	LYNX Medical Pennsylvania	ERIE, PA, US
1649518	Sterigenics US LLC	Fort Worth, TX, US
3005669815	AMSINO MEDICAL (KUNSHAN) CO., LTD.	KUNSHAN CITY Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025772870. Last updated year: 2026. Please use registration number 3025772870 when referencing this establishment in official correspondence.