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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

BE-ST NAV PAK Needle

UDI-DI 00853508002331Basic UDI-DI 0853508002TD07UJ

Class IIa · MDR · Lacey Manufacturing Company LLC

Identification
Model
PK1011
EMDN
A0399
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)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/be-st-nav-pak-needle-2331 · UDI page: /udi/00853508002331

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