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Snapshot 2026-10-13 · Link to EUDAMED

Legacy device

Makoto Intravascular Imaging System™

UDI-DI 00857595006432Basic UDI-DI B-00857595006432

Class IIa · MDD (legacy) · Nipro Vascular Innovations Americas, Inc.

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Identification

Model: TVC-MC10/TVC-MC10i
EMDN: C019004
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: Yes
Reusable surgical: No

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

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/makoto-intravascular-imaging-systemtm-6432 · UDI page: /udi/00857595006432

All devices from Nipro Vascular Innovations Americas, Inc.

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