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Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

HYALFORTE INJECTION

UDI-DI 08806103800101Basic UDI-DI 880610380010CB

Class III · MDR · Shin poong Pharm Co.,Ltd.

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

2025-MDR/TD-048

EU technical documentation assessment · valid

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

Valid from 2025-09-24 · Expiry 2027-09-27

Scope not stated in certificate data.

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

2025-MDR/QS-048

EU quality management system · valid

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

Valid from 2025-09-24 · Expiry 2027-09-27

Scope not stated in certificate data.

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

Manufacturer

Shin poong Pharm Co.,Ltd.

SRN KR-MF-000009206

KR · Ansan-si

manufacturer

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

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hyalforte-injection-0101 · UDI page: /udi/08806103800101

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