Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

GuideRight

UDI-DI 00816349013621Basic UDI-DI 081634901PTFEVASN2

Class III · MDR · Lake Region Medical

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Identification

Model: —
EMDN: C04020102
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

TD745.179

EU technical documentation assessment · valid

Notified body: National Standards Authority of Ireland (NSAI) (0050)

Valid from 2025-12-16 · Expiry 2030-12-15

Scope not stated in certificate data.

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

Manufacturer

Lake Region Medical

SRN US-MF-000033013

US · Minnesota

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/guideright-3621 · UDI page: /udi/00816349013621

All devices from Lake Region Medical

Scan an inventory CSV