Skip to content
UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-25 · Link to EUDAMED

Dualpro IVUS+NIRS Imaging Catheter

UDI-DI 00857595006494Basic UDI-DI 0857595006CNUC8

Class III · MDR · Nipro Vascular Innovations Americas, Inc.

Identification
Model
TVC-C195-42
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

MDR 766211

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-08-07 · Expiry 2027-12-19

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Nipro Vascular Innovations Americas, Inc.

SRN US-MF-000002341

US · Bedford, Massachusetts

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/dualpro-ivus-nirs-imaging-catheter-6494 · UDI page: /udi/00857595006494

Scan an inventory CSV