Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681410

FEI Number

1000339531

Entity Name

T.G. EAKIN, LTD.

City/State/Country

COMBER, COUNTY DOWN Ards and North Down, GB

Establishment Address

15 BALLYSTOCKART RD., COMBER, COUNTY DOWN Ards and North Down BT23 5QY, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

T.G. EAKIN, LTD. (Owner Number: 9014145)

Owner / Operator Contact Address

15 BALLYSTOCKART RD., --, COMBER, COUNTY DOWN, GB-NOTA BT23 5QY, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EAKIN FISTULA AND WOUND POUCHES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1995-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

T.G. EAKIN, LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681410. Last updated year: 2026. Please use registration number 9681410 when referencing this establishment in official correspondence.