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Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating

UDI-DI 00813132026936Basic UDI-DI 081313202BM402LN

Class III · MDR · Philips Image Guided Therapy Corporation

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 731457

EU technical documentation assessment · valid

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

Valid from 2026-11-04 · Expiry 2031-11-03

Scope not stated in certificate data.

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

Manufacturer

Philips Image Guided Therapy Corporation

SRN US-MF-000018632

US · Colorado Springs

manufacturer

Authorised representative: Philips Medical Systems Nederland B.V. (NL-AR-000001422)

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Canonical device page: /device/angiosculpt-evo-rx-ptca-scoring-balloon-catheter-with-hydrop-6936 · UDI page: /udi/00813132026936

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