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VASCUTEK LIMITED

United Kingdom of Great Britain and Northern Ireland · Inchinnan

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 0Class II 3Class III 4

plus 24 registration records and 26 510(k), 18 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

24active device licences

Class II 1Class III 1Class IV 22

29 including historic records

TWTaiwanTFDA

3valid device licences

Class II 2Class III 1

SGSingaporeHSA SMDR

8device registrations

CLASS B 1CLASS C 1CLASS D 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

4active ARTG entries

Class III 4

HKHong KongMDACS

5valid listings

Class IV 5

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

5active registrations

Class 3 5

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States24 registration records, 26 510(k), 18 PMA

Canada24 confirmed, 0 excluded

Manufacturer names merged into this page: VASCUTEK LTD. · VASCUTEK LIMITED

Business registration

Company number: SC079773
Registration status: Active
Legal form: Private Limited Company
Incorporated: 1982-08-16
Principal activity: 32500 - Manufacture of medical and dental instruments and supplies
Registered address: NEWMAINS AVENUE, RENFREWSHIRE, PA4 9RR

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

41991

11995

21996

11997

12003

32004

12005

12006

12007

42009

12010

22017

12020

12021

12024

12025

FDA listed device types

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 1Graft, Vascular, Synthetic/Biologic Composite 1Prosthesis, Vascular Graft, Of 6mm And Greater Diameter 1Heart-Valve, Non-Allograft Tissue 1Hybrid Stent Graft, Thoracic Aortic Lesion Treatment 1Heart-Valve, Mechanical 1Ventricular (Assist) Bypass 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241550	Gelweave Vascular Prostheses	2025-02-27
US	K241070	Gelsoft Plus Vascular Prostheses	2024-11-15
US	K202703	Vascutek Gelsoft Plus ERS Vascular Graft	2021-04-06
CA	9070	VASCUTEK VASCUSOFT PLUS VASCULAR PROSTHESIS	Class IV
CA	9076	VASCUTEK VASCUSOFT (VP1200K) VASCULAR PROSTHESIS	Class IV
CA	9255	VASCUTEK GELSEAL VASCULAR PROSTHESIS	Class IV