Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003315146

FEI Number

3003315146

Entity Name

CALTAG MEDSYSTEMS LTD

City/State/Country

Buckingham Buckinghamshire, GB

Establishment Address

Whiteleaf Business Centre, 11 Little Balmer,, Buckingham Buckinghamshire MK18 1TF, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Caltag Medsystems (Owner Number: 10052081)

Owner / Operator Contact Address

Whiteleaf Business Centre, 11 Little Balmer,, Buckingham, GB-BKM MK18 1TF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162723

PMA Number

N/A

All Registered Proprietary Names

TransFix TransFix/EDTA Vacuum Blood Collection Tubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2016-06-10
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2017-06-27

Official Correspondent

Dean Coupar

US Agent Details

Jeremy Harlan Business: Cedarlane Laboratories U.S.A. Inc, Email: Jeremy.Harlan@cedarlanelabs.com Phone: (336) 5135135

Related Public Records

Same Entity

Caltag Medsystems

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 3003315146. Last updated year: 2026. Please use registration number 3003315146 when referencing this establishment in official correspondence.