Venturemed Group, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000022041
- Devices
- 5
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Venturemed Group, Inc. makes
Venturemed Group, Inc. manufactures cutting/scoring coronary angioplasty balloon catheters, including the FLEX Vessel Prep System. These devices are designed for preparing coronary arteries prior to stent placement or angioplasty by creating controlled vessel cuts or scores to improve blood flow.
The company’s products are classified as Class II devices under US regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The portfolio is authorised for commercial distribution in the United States.
Catalogue
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
Flex Scoring Catheter Ref K152789
Regimes: 510(k) Registry: 510(k)FLEX Vessel Prep System Ref K202187
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000022041
- DUNS number
- 027796091
- EU VAT number
- DE339657493
- EUDAMED status
- Active
- EUDAMED registered name
- VentureMed Group, Inc.
- Registered address
- 2800, Campus Drive, 55441, Plymouth, United States
- Website
- www.venturemedgroup.com
- [email protected]
- PRRC contact
- Jill Schweiger
Frequently asked questions
How many devices does Venturemed Group, Inc. have in the registry?
The registry currently lists 5 devices for Venturemed Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Venturemed Group, Inc.'s devices?
Among its 5 most recently registered devices, Venturemed Group, Inc. has devices listed in EUDAMED (3 devices), FDA 510(k) (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Venturemed Group, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Venturemed Group, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Venturemed Group, Inc. in the registry?
The most recently registered devices listed for Venturemed Group, Inc. include FLEX Vessel Prep System FSC 4-75, FLEX Vessel Prep System FSC 4-40, FLEX Vessel Prep System FSC 4-120 and FLEX SCORING CATHETER.