Venclose Inc
Active in EUDAMEDUnited 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
- Registries
- FDA GUDID 22
- EUDAMED 9
- FDA 510(k) 4
- Device classes
- FDA Class II 17
- EU Class I 6
- EU Class IIb 3
- Top EMDN categories
- Sites and related companies
- ICON (LR) Limited authorised representative
- Identifiers
- EUDAMED SRN US-MF-000001372
- DUNS 085838983
At a glance
EU certificates
1 of 1 in force.
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.
Catalogue
Search and filter all 26 devicesCompany details
- 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
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 29 Aug 2028
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.