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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

REJURAN i (pouch)

UDI-DI 08800051000040Basic UDI-DI 0880005100M148257G

Class III · MDR · PharmaResearch Co., Ltd.

Identification
Model
REJURAN, REJURAN i, REJURAN s, M2-001, M2-002, M2-003
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2024-AXVI/TD-001/A

EU technical documentation assessment · valid

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

Valid from 2025-11-11 · Expiry 2029-12-12

Scope not stated in certificate data.

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

2024-AXVI/QS-001/A

EU quality management system · valid

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

Valid from 2025-11-11 · Expiry 2029-12-12

Scope not stated in certificate data.

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

Manufacturer

PharmaResearch Co., Ltd.

SRN KR-MF-000031646

KR · Gangneung-si, Gangwon-do

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/rejuran-i-pouch-0040 · UDI page: /udi/08800051000040

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