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UDI Compass

LAFULLEN

Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 08809961546693Basic UDI-DI 880976632FI01LU

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Class III · MDR · Samyang Biopharm Corporation

Identification

Model
DMFI300, DMFI300D
EMDN
X0303
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No

Certificates

2026-AXVI/TD-003/A

EU technical documentation assessment · unknown

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

Valid from 2026-09-28 · Expiry 2029-12-12

Scope not stated in certificate data.

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

2026-AXVI/QS-003/A

EU quality management system · unknown

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

Valid from 2026-09-28 · Expiry 2026-12-12

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

NameUDI-DICertificate
LAFULLEN08809766321334
Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/lafullen-6693 · UDI page: /udi/08809961546693

All devices from Samyang Biopharm Corporation