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UDI Compass
Certificate valid

Snapshot 2026-10-18 · Link to EUDAMED

DynamX Sirolimus Eluting Coronary Bioadaptor System

UDI-DI 00817508012981Basic UDI-DI 081750801DynamXVIR4F

Class III · MDR · Elixir Medical Corporation

Identification
Model
VIR2014
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2025-MDR/TD-051

EU technical documentation assessment · valid

Notified body: 3EC International a.s. (2265)

Valid from 2025-11-10 · Expiry 2029-11-08

Scope not stated in certificate data.

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

2025-MDR/QS-051

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2025-11-10 · Expiry 2029-11-08

Scope not stated in certificate data.

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

Manufacturer

Elixir Medical Corporation

SRN US-MF-000013041

US · Milpitas

manufacturer

Authorised representative: Acorn Regulatory Consultancy Services Ltd (IE-AR-000000592)

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Canonical device page: /device/dynamx-sirolimus-eluting-coronary-bioadaptor-system-2981 · UDI page: /udi/00817508012981

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