Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

BE-ST NIM Pedicle Probe Lumbar

UDI-DI 00853508002355Basic UDI-DI 0853508002TD06UG

Class IIa · MDR · Lacey Manufacturing Company LLC

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Identification

Model: PK1013
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 NIM Pedicle Probe 00853508002348
BE-ST NIM Pedicle Probe 00853508002461
BE-ST NIM Pedicle Probe 00853508002454
BE-ST NIM Pedicle Probe Straight 00853508002362
BE-ST NIM Pedicle Probe Thoracic 00853508002447

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/be-st-nim-pedicle-probe-lumbar-2355 · UDI page: /udi/00853508002355

All devices from Lacey Manufacturing Company LLC

Scan an inventory CSV