Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029904425

FEI Number

3029904425

Entity Name

Lightpoint Surgical Limited

City/State/Country

AMERSHAM Hertfordshire, GB

Establishment Address

St. Marys Court City, AMERSHAM Hertfordshire HP7 0UT, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Lightpoint Surgical Ltd (Owner Number: 10089037)

Owner / Operator Contact Address

Ronda Europa 74, nave 27 Poligon Ind., Santa Magdalena, Vilanova i la Geltrú, ES-B 08800, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SENSEI V2 (Reusable Probe) System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2023-10-31

Official Correspondent

Claire Woodthorpe

US Agent Details

Nynke van den Berg Business: Telix Pharmaceuticals Email: nynke.vandenberg@telixpharma.com Phone: (650) 3347015

Related Public Records

Same Entity

Lightpoint Surgical Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K942580	Neoprobe Corp.	NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES	1995-02-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029904425. Last updated year: 2026. Please use registration number 3029904425 when referencing this establishment in official correspondence.