Vivasure Medical Ltd.

Ireland IE-MF-000000651 Last updated 21 Oct 2026

Devices: 8
Registries: EUDAMEDFDA 510(k)
FDA recalls: 0

Catalogue8

PerQseal Introducers Ref K252309

Class II FDA 510(k) Active
PerQseal® Elite Closure Device Ref DP4-FA1-4-G

Class III EUDAMED Active
PerQseal Ref DP2-FA1-6-G

Class IIa EUDAMED Active
PerQseal+ Ref DP2-P2-L-G

Class III EUDAMED Active
PerQseal Ref DP2-FA1-5-G

Class IIa EUDAMED Active
PerQseal® Elite Ref DP4-P1-2-G

Class III EUDAMED Active
PerQseal Ref DP2-P1-S-G

Class III EUDAMED Active
PerQseal Ref DP2-P1-L-G

Class III EUDAMED Active

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

TÜV SÜD Product Service GmbH 0123 2 certificates

G15 072208 0005 Issued

Quality management system EU MDR

Issued
14 Apr 2025

Expires
10 Apr 2030
G70 072208 0004 Supplemented

Technical documentation EU MDR

Issued
20 Jun 2025

Expires
10 Apr 2030

Reason
Change approved

Notified bodies

TÜV SÜD Product Service GmbH 0123

About

Pioneering the Future of Large-Bore Vessel Closure for Arterial and Venous Access. The first and only 100% bio-absorbable, sutureless patch..

From the manufacturer's own website. Source

Information

Country: Ireland(from SRN)
Address: Parkmore Business Park West, Galway, Ireland
Website: www.vivasuremedical.com
LinkedIn: linkedin.com/company/vivasure-medical
Email: [email protected]
Phone: 00353 91 395 440
EUDAMED SRN: IE-MF-000000651