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Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

PULSTA™ Transcatheter Pulmonary Valve System

UDI-DI 08809643759861Basic UDI-DI 880964375TPVWW

Class III · MDR · Taewoong Medical Co., Ltd.

Identification
Model
TPV1828
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR 796279

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-01-21 · Expiry 2031-01-20

Scope not stated in certificate data.

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

Manufacturer

Taewoong Medical Co., Ltd.

SRN KR-MF-000007515

KR · Gimpo-si, Gyeonggi-do

manufacturer

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

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Canonical device page: /device/pulstatm-transcatheter-pulmonary-valve-system-9861 · UDI page: /udi/08809643759861

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