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Venclose Inc

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000001372

Venclose Inc is a medical device manufacturer based in the United States, with 26 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I and IIb) as of 15 Nov 2026.

Devices
26
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 22
  • EUDAMED 9
  • FDA 510(k) 4

A device listed in two registries counts in both.

Device classes
  • FDA Class II 17
  • EU Class I 6
  • EU Class IIb 3
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000001372
  • DUNS 085838983

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
Authorised rep.
ICON (LR) LimitedIE

What Venclose Inc makes

Venclose Inc manufactures single-use peripheral vascular electrocautery catheters, electrical mains power cables for medical systems, and foot-switches for surgical procedures. Their product line includes procedure kits and specialized catheters designed for vascular interventions, as well as power cords and foot pedals for surgical equipment.

The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIb, with listings in the EU’s eudamed database and FDA registries for 510(k) clearances and UDI compliance. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue26

Newest first, rows 1-26 of 26

Search and filter all 26 devices
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Rows 1-26 of 26

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000001372
DUNS number
085838983
EU VAT number
205/5978/0567
EUDAMED status
Active
EUDAMED registered name
Venclose, Inc.
Registered address
2570, N. First Street, 95131, San Jose, United States
Website
venclose.com
Phone
+1 8448346292
PRRC contact
Jay Sharma(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 29 Aug 2028

EUDAMED certificates (1)

DNV Product Assurance AS 2460 1 certificate

  • 10000475258-PA-NoMA-USA Active

    Quality management system EU MDR

    Issued
    29 Aug 2023
    Expires
    29 Aug 2028

Frequently asked questions

How many devices does VENCLOSE INC have in the registry?

The registry currently lists 26 devices for VENCLOSE INC. Devices recorded under merged duplicate company entries are counted once.

Which registries list VENCLOSE INC's devices?

Among its 26 most recently registered devices, VENCLOSE INC has devices listed in EUDAMED (9 devices), FDA 510(k) (4 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do VENCLOSE INC's devices fall under?

Among its 26 most recently registered devices, the classes recorded for VENCLOSE INC's devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for VENCLOSE INC?

EUDAMED lists 1 certificate for VENCLOSE INC (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 29 Aug 2023.

What are the newest devices from VENCLOSE INC in the registry?

The most recently registered devices listed for VENCLOSE INC include Venclose System Power Cord VCPCN, Venclose™ EVSRF™ Catheter VC-10A2.5-6F-60 [10X], Venclose System Power Cord VCPCC and Venclose System Power Cord VCPCH.

Generated automatically from registry data and not verified by a human reviewer.