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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Rapi-Gide

UDI-DI 08809201010045Basic UDI-DI 880920101DALIMDTGNM

Class III · MDR · Dalim Tissen Co., Ltd.

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

2024-MDR/TD-056/C

EU technical documentation assessment · unknown

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

Valid from 2026-08-11 · Expiry 2029-09-12

Scope not stated in certificate data.

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

2024-MDR/QS-056/C

EU quality management system · unknown

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

Valid from 2026-08-11 · Expiry 2029-09-12

Guided tissue and bone regeneration membrane and plug: Rapi-Gide, Diaderm M, Diaderm Plug, Ti-oss Guide, WA Mem

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

Manufacturer

Dalim Tissen Co., Ltd.

SRN KR-MF-000020019

KR · Seoul

manufacturer

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

Related UDI-DIs

Showing 12 of 33 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/rapi-gide-0045 · UDI page: /udi/08809201010045

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