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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

IMPEDE-FX Embolization Plug, 8mm

UDI-DI 00810041650047Basic UDI-DI 081004165IMP8Z

Class III · MDR · Shape Memory Medical Inc

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

1000275865

EU technical documentation assessment · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2025-12-19 · Expiry 2030-12-18

Scope not stated in certificate data.

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

1000156813

EU quality management system · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2025-12-19 · Expiry 2030-12-18

Scope not stated in certificate data.

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

Manufacturer

Shape Memory Medical Inc

SRN US-MF-000008157

US · San Jose

manufacturer

Authorised representative: MedR-AR Services B.V. (NL-AR-000000120)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/impede-fx-embolization-plug-8mm-0047 · UDI page: /udi/00810041650047

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