EUDAMED device

Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

EUDAMED device 00813132027278 · Spectranetics Corporation

Key facts

Primary DI 00813132027278
Trade name Stellarex 0.035" OTW Drug-coated Angioplasty Balloon
Device name Stellarex .035 OTW Drug-coated Angioplas
Reference or catalog number A35SX040080135
Manufacturer Spectranetics Corporation
Manufacturer SRN US-MF-000020669
Risk class Class III
EMDN code C010402020101
EMDN description PTA BALLOON DILATATION CATHETERS
Legislation mdd
Implantable No
Sterile Yes
Single use Yes
Status date Jan 8, 2025

At a glance

  • No Matching FDA GUDID record

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About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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