Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006892175

FEI Number

3006892175

Entity Name

TRISTEL SOLUTION LTD

City/State/Country

Snailwell Cambridgeshire, GB

Establishment Address

Unit 1b, Lynx Business Park, Fordham Road, Snailwell Cambridgeshire CB8 7NY, GB

Establishment Type(s)

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

Owner / Operator

Tristel Solution Ltd (Owner Number: 10088469)

Owner / Operator Contact Address

Unit 1b, Lynx Business Park, Fordham Road, Snailwell, GB-CAM CB8 7NY, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242732

PMA Number

N/A

All Registered Proprietary Names

Tristel OPH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QWS	Foam Or Gel Chemical Sterilant/High Level Disinfectant	General Hospital	Class 2	880.6886	2025-06-24

Official Correspondent

Julija Shabanova

US Agent Details

Mika Nishimura Email: mika@blggroup.com Phone: (650) 2187581

Related Public Records

Same Entity

Tristel Solution 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 3006892175. Last updated year: 2026. Please use registration number 3006892175 when referencing this establishment in official correspondence.