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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Terason uSmart3300 USB3

UDI-DI 00852698007225Basic UDI-DI 852698007225JH

Class IIa · MDR · Teratech Corporation

Identification
Model
Terason uSmart3300 USB3
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

28620253687

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2026-08-13 · Expiry 2031-03-01

Scope not stated in certificate data.

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

Manufacturer

Teratech Corporation

SRN US-MF-000033295

US · Burlington

manufacturer

Authorised representative: Wellkang Ltd (XI-AR-000001836)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/terason-usmart3300-usb3-7225 · UDI page: /udi/00852698007225

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