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UDI Compass

Duodenal/Pyloric Stent with Delivery System

Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 08806367007001Basic UDI-DI 88063670DUOC007S3

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Class IIb · MDR · M.I.Tech Co., Ltd

Identification

Model
HANAROSTENT® TwynLay™ Duodenum/Pylorus (NCN)
EMDN
P0503
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No

Certificates

G70 080984 0025

EU technical documentation assessment · unknown

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-07-09 · Expiry 2028-08-30

Scope not stated in certificate data.

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

Manufacturer

M.I.Tech Co., Ltd

SRN KR-MF-000011623

KR · Pyeongtaek-si, Gyeonggi-do

manufacturer

Authorised representative: KTR Europe GmbH (DE-AR-000005685)

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Showing 12 of 43 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/duodenal-pyloric-stent-with-delivery-system-7001 · UDI page: /udi/08806367007001

All devices from M.I.Tech Co., Ltd