Venclose, Inc.

Certificate 10000475258-PA-NoMA-USA

Rev. 0Issued

Valid until: Aug 29, 2028

Certificate 10000475258-PA-NoMA-USA is a valid Quality management system issued to Venclose, Inc. and registered in EUDAMED. Valid until August 29, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000475258-PA-NoMA-USA
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000475258-PA-NoMA-USA0

Validity

Issued: Aug 29, 2023
Valid from: Aug 29, 2023
Valid until: Aug 29, 2028

Manufacturer

Manufacturer: Venclose, Inc.
Manufacturer SRN: US-MF-000001372
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb5

5 scopes

digiRF Generator (Generator used with the EVSRF System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.)
Class IIb
Venclose EVSRF Catheter (EVSRF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.)
Class IIb
Venclose digiRF Generator (model#VCOUSRFG1)
Class IIb
Venclose EVSRF Catheter, 60cm (model# VCOUS6F60)
Class IIb
Venclose EVSRF Catheter, 100cm (model# VCOUS6F100)
Class IIb

Documents

LanguagesEN