Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038293255

FEI Number

3038293255

Entity Name

SURGEASE INNOVATIONS LTD

City/State/Country

Berkshire England, GB

Establishment Address

SurgEase Innovations Ltd, First floor Burlington house 1-13 York Road, Berkshire England SL6 1SQ, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Surgease innovations ltd (Owner Number: 10093836)

Owner / Operator Contact Address

SurgEase Innovations Ltd, First floor Burlington house 1-13 York Road, Berkshire, GB-ENG SL6 1SQ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LumenEye X1 SESIS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAN	Sigmoidoscope, Rigid, Electrical	Gastroenterology, Urology	Class 2	876.1500	2025-07-19
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2026-05-08

Official Correspondent

ZULFY MUHUSEEN

US Agent Details

Archana Natarajan Email: archana.natarajan@surgease.co.uk Phone: (347) 7696780

Related Public Records

Same Entity

Surgease innovations 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 3038293255. Last updated year: 2026. Please use registration number 3038293255 when referencing this establishment in official correspondence.