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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-17 · Link to EUDAMED

MONOFIX PDO

UDI-DI 08809366476991Basic UDI-DI 880936647KM01MT

Class III · MDR · Samyang Biopharm Corporation

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

2024-MDR/TD-067/B

EU technical documentation assessment · unknown

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

Valid from 2026-01-05 · Expiry 2029-12-12

Scope not stated in certificate data.

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

2024-MDR/QS-067/B

EU quality management system · unknown

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

Valid from 2026-01-05 · Expiry 2029-12-12

Scope not stated in certificate data.

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

Manufacturer

Samyang Biopharm Corporation

SRN KR-MF-000037085

KR · Daedeok-gu, Daejeon

manufacturer

Authorised representative: Samyang Biopharm Magyarország Kft. (HU-AR-000035346)

Related UDI-DIs

Showing 12 of 174 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/monofix-pdo-6991 · UDI page: /udi/08809366476991

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