Nipro Vascular Innovations Americas, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000002341 FEI 3003524171
- Devices
- 12
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
- Authorised rep.
- Emergo Europe B.V.NL
Catalogue
TVC Imaging System™ TVC-MC8 Ref TVC-MC8
TVC Imaging System™ TVC-MC9 Ref TVC-MC9
TVC Insight™ TVC-C195-20 Ref TVC-C195-20
TVC Insight™ TVC-C195-22 Ref TVC-C195-22
TVC Integrated Imaging System™ TVC-MC9i Ref TVC-MC9i
TVC Imaging System™ TVC-MC8 Ref TVC-MC8
Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit TVC-E195-42 Ref TVC-E195-42
TVC Insight XB™ TVC-C195-32 Ref TVC-C195-32
TVC Controller Sterile Barrier TVC-MC8-B1 Ref TVC-MC8-B1
Makoto Intravascular Imaging System™ Ref TVC-MC10
Dualpro™ IVUS+NIRS Imaging Catheter Ref TVC-C195-42
Company details
- EUDAMED SRN
- US-MF-000002341
- FDA FEI number
- 3003524171
- DUNS number
- 124065421
- EUDAMED status
- Active
- EUDAMED registered name
- Nipro Vascular Innovations Americas, Inc.
- Registered address
- 28 Crosby Drive, 01730, Bedford, Massachusetts, United States
- Website
- niprovascularinnovations.com/
- [email protected]
- Phone
- +1 888-680-7339
- PRRC contact
- Nozomi Yagi
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 19 Dec 2027
Notified body 2797 2 certificates
- MDR 766209 Amended
Quality management system EU MDR
- Issued
- 7 Aug 2026
- Expires
- 19 Dec 2027
- Reason
- Mnf data change
- MDR 766211 Amended
Technical documentation EU MDR
- Issued
- 7 Aug 2026
- Expires
- 19 Dec 2027
- Reason
- Mnf data change
From the company website
Nipro Vascular Innovations Americas develops high-resolution intravascular imaging technologies aimed at conquering vascular disease.
Frequently asked questions
How many devices does Nipro Vascular Innovations Americas, Inc. have in the registry?
The registry currently lists 12 devices for Nipro Vascular Innovations Americas, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nipro Vascular Innovations Americas, Inc.'s devices?
Among its 12 most recently registered devices, Nipro Vascular Innovations Americas, Inc. has devices listed in EUDAMED (2 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nipro Vascular Innovations Americas, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Nipro Vascular Innovations Americas, Inc.'s devices are Class IIa, Class II and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Nipro Vascular Innovations Americas, Inc.?
EUDAMED lists 2 certificates for Nipro Vascular Innovations Americas, Inc. (quality management system; technical documentation) under MDR. The most recent was issued on 2026-08-07.
What are the newest devices from Nipro Vascular Innovations Americas, Inc. in the registry?
The most recently registered devices listed for Nipro Vascular Innovations Americas, Inc. include TVC Imaging System™ TVC-MC8, TVC Imaging System™ TVC-MC9, TVC Insight™ TVC-C195-20 and Makoto Integrated Intravascular Imaging System™ TVC-MC10i.