Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043496870

FEI Number

3043496870

Entity Name

Javelo Health Limited

City/State/Country

Edinburgh East Lothian, GB

Establishment Address

Suite 2 Ground Floor Orchard Brae House, 30 Queensferry Road, Edinburgh East Lothian EH4 2HS, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Javelo Health Limited (Owner Number: 10093328)

Owner / Operator Contact Address

Suite 2 Ground Floor Orchard Brae House, 30 Queensferry Road, Edinburgh, GB-ELN EH4 2HS, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Javelo Peripheral Line Securement

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2025-04-30

Official Correspondent

Ashton Barnett-Vanes

US Agent Details

Randy Hoffman Email: randy@javelo.health Phone: (720) 2555812

Related Public Records

Same Entity

Javelo Health 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 3043496870. Last updated year: 2026. Please use registration number 3043496870 when referencing this establishment in official correspondence.