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Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Dorothy

UDI-DI 08800052003231Basic UDI-DI 88000520CFN019Z

Class III · MDR · CHA Meditech Co., Ltd.

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

2026-AXVI/TD-001

EU technical documentation assessment · valid

Notified body: 3EC International a.s. (2265)

Valid from 2026-01-07 · Expiry 2031-01-07

Scope not stated in certificate data.

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

2026-AXVI/QS-001

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2026-01-07 · Expiry 2031-01-07

Scope not stated in certificate data.

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

Manufacturer

CHA Meditech Co., Ltd.

SRN KR-MF-000008782

KR · Daejeon

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

Showing 12 of 29 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/dorothy-3231 · UDI page: /udi/08800052003231

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