Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007441619

FEI Number

3007441619

Entity Name

GBUK GROUP LIMITED

City/State/Country

Selby North Yorkshire, GB

Establishment Address

Woodland House, Blackwood Hall Business Park, North Duffield, Selby North Yorkshire YO8 5DD, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GBUK Group Limited (Owner Number: 10056284)

Owner / Operator Contact Address

Woodland House, Blackwood Hall Business Park, North Duffield, Selby, GB-NYK YO8 5DD, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-03-07
JLL	Tubeless Analysis, Gastric Acidity	Clinical Chemistry	Class 1	862.1320	2019-01-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-04-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-04-16
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-04-16
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2019-12-02
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2019-12-02
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-10-22
PIO	Enteral Specific Transition Connectors	Gastroenterology, Urology	Class 2	876.5980	2022-12-01
INE	Sling, Overhead Suspension, Wheelchair	Physical Medicine	Class 1	890.3910	2020-10-20
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2020-06-29
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2021-02-02
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2019-12-20
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2021-04-19
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2019-07-05
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2017-11-24
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2018-02-01
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2018-02-01
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2018-02-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-02-01
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2021-01-27
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2018-02-01
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2019-07-05
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2019-12-03

Official Correspondent

Chloe Kelly

US Agent Details

Bryan Brosseau Business: Brosseau Consulting LLC Email: bryan@brosseauconsult.com Phone: (404) 6107215

Related Public Records

Same Entity

GBUK Group Limited

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007441619. Last updated year: 2026. Please use registration number 3007441619 when referencing this establishment in official correspondence.