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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

GEMS Soft Harvest System

UDI-DI 00819127023348Basic UDI-DI 081912702DCHVST59

Class IIa · MDR · Tulip Medical Products, Inc.

Identification
Model
DC1SLCAR1315-01
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

28620236355-01

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2026-09-29 · Expiry 2030-06-30

Scope not stated in certificate data.

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

Manufacturer

Tulip Medical Products, Inc.

SRN US-MF-000049097

US · San Diego

manufacturer

Authorised representative: MedEnvoy Global BV (NL-AR-000024028)

Related UDI-DIs

Showing 12 of 23 other UDI-DIs.

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Canonical device page: /device/gems-soft-harvest-system-3348 · UDI page: /udi/00819127023348

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