Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034205503

FEI Number

3034205503

Entity Name

ST ANDREWS MEDICAL INNOVATIONS LIMITED

City/State/Country

St Andrews Fife, GB

Establishment Address

Walter Bower House, Guardbridge, St Andrews Fife KY16 0US, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ST ANDREWS MEDICAL INNOVATIONS LIMITED (Owner Number: 10092191)

Owner / Operator Contact Address

Walter Bower House, Guardbridge, St Andrews, GB-FIF KY16 0US, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arclight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2024-12-12

Official Correspondent

Edwin Lindsay

US Agent Details

Edwin Lindsay Business: RAF Solutions Inc Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

ST ANDREWS MEDICAL INNOVATIONS 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 3034205503. Last updated year: 2026. Please use registration number 3034205503 when referencing this establishment in official correspondence.