PULSTA™ Transcatheter Pulmonary Valve System

by Taewoong Medical Co., Ltd. South Korea EUDAMED

Ref TPV1828

EMDN P070301030103

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number880964375TPVWW Basic UDI-DI	Date19 Aug 2026Registered	StatusActive
European Union	CE/MDR	NumberMDR 796279	Date21 Jan 2026Issued	StatusActive expires 20 Jan 2031

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

EU market availability

Available in 32 countries, as listed in EUDAMED:

Last checked 23 Oct 2026.

Certificates

1 certificate · EUDAMED

MDR 796279 Issued

Technical documentation EU MDR

Notified body

Notified body 2797

Issued
21 Jan 2026

Expires
20 Jan 2031

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Transcatheter Pulmonary Valve
Model / Reference: TPV1828

Primary DI / UDI-DI: 08809643759854
Basic UDI-DI: 880964375TPVWW
EMDN Code: P070301030103 Stented biological pulmonary valves for percutaneous implant - valve tissue of animal origin

Device Class: Class III
Market of Registration: Poland

Manufacturer details

EUDAMED SRN: KR-MF-000007515
Authorised representative: Emergo Europe B.V. NL-AR-000000116

Properties & raw data

Show properties, registry sources and raw records

Sterile
Implantable
CMR Substance
Animal Tissues

Other properties (9)

Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No

Sources (1)

EUDAMED 08809643759854|880964375TPVWW 61 fields · synced 22 Oct 2026