Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

BE-ST Sheathed Surgical Knife

UDI-DI 00853508002003Basic UDI-DI 0853508002TD03UA

Class IIa · MDR · Lacey Manufacturing Company LLC

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Identification

Model: 1571-00
EMDN: V010101
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

28620146584-04

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2025-01-17 · Expiry 2027-06-27

Scope not stated in certificate data.

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

Manufacturer

Lacey Manufacturing Company LLC

SRN US-MF-000037674

US · Bridgeport

manufacturer

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

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Canonical device page: /device/be-st-sheathed-surgical-knife-2003 · UDI page: /udi/00853508002003

All devices from Lacey Manufacturing Company LLC

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