Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012895304

FEI Number

3012895304

Entity Name

CUI International Limited

City/State/Country

Burbage Hinckley Leicestershire, GB

Establishment Address

Unit 18 Waterfield Way, Burbage Hinckley Leicestershire LE10 3ER, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CUI International Limited (Owner Number: 10050652)

Owner / Operator Contact Address

Unit 18 Waterfield Way, Burbage Hinckley, GB-LEC LE10 3ER, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BHIS Bra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2025-04-30

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

CUI International 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 3012895304. Last updated year: 2026. Please use registration number 3012895304 when referencing this establishment in official correspondence.