Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014018042

FEI Number

3014018042

Entity Name

ADAPTIX LIMITED

City/State/Country

Oxford Oxfordshire, GB

Establishment Address

Adaptix Ltd, Centre for Innovation & Enterprise, Oxford University Begbroke Science Park, Oxford Oxfordshire OX5 1PF, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Adaptix Limited (Owner Number: 10093403)

Owner / Operator Contact Address

Adaptix Ltd, Centre for Innovation & Enterprise, Oxford University Begbroke Science Park, Oxford, GB-OXF OX5 1PF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252133

PMA Number

N/A

All Registered Proprietary Names

Adaptix Ortho350

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2025-11-17

Official Correspondent

Martin Stofanko

US Agent Details

Stephan Toupin Business: DAWA Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Adaptix 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 3014018042. Last updated year: 2026. Please use registration number 3014018042 when referencing this establishment in official correspondence.