Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016585381

FEI Number

3016585381

Entity Name

FBGC LIMITED

City/State/Country

Bridlington East Riding of Yorkshire, GB

Establishment Address

Medina House, 2 Station Avenue, Bridlington East Riding of Yorkshire YO16 4LZ, GB

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

FBGC Limited (Owner Number: 10062652)

Owner / Operator Contact Address

Medina House, 2 Station Avenue, Bridlington, GB-ERY YO16 4LZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medi Grade Medi Grade Medi Grade Medi Grade Medi Grade Medi Grade Medi Grade

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCM	Dropper, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-03-08
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2020-02-26
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2020-02-26
KIP	Formulations, Balanced Salt Solutions	Hematology	Class 1	864.2875	2026-01-14
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2022-12-19
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2022-12-15
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2025-08-08
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-12-04
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2026-01-14
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2026-02-03
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2022-12-15

Official Correspondent

Sam Coleman

US Agent Details

Sam Coleman Business: FBGC Limited Email: sam@fbgc.co.uk Phone: (347) 2046089

Related Public Records

Same Entity

FBGC Limited

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 3016585381. Last updated year: 2026. Please use registration number 3016585381 when referencing this establishment in official correspondence.