Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

BE-ST PAK Needle

UDI-DI 00853508002232Basic UDI-DI 0853508002TD04UC

Class IIa · MDR · Lacey Manufacturing Company LLC

Scan an inventory CSV

Identification

Model: PK1001
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

BE-ST PAK Needle 00853508002249
BE-ST PAK Needle 00853508002218
BE-ST PAK Needle 00853508002256
BE-ST PAK Needle 00853508002225

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/be-st-pak-needle-2232 · UDI page: /udi/00853508002232

All devices from Lacey Manufacturing Company LLC

Scan an inventory CSV