Unknown / Not in EUDAMED

Snapshot 2026-10-18 · Link to EUDAMED

Big-Tip

UDI-DI 08809559963291Basic UDI-DI 880014291604BD

Class IIb · MDR · RF Medical Co., Ltd.

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Identification

Model: BT Series
EMDN: K0201010301
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

KR23/00000154

EU quality management system · unknown

Notified body: SGS Belgium NV (1639)

Valid from 2026-04-23 · Expiry 2028-09-21

Scope not stated in certificate data.

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

Manufacturer

RF Medical Co., Ltd.

SRN KR-MF-000012647

KR · Seoul

manufacturer

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

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Showing 12 of 411 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/big-tip-3291 · UDI page: /udi/08809559963291

All devices from RF Medical Co., Ltd.

Scan an inventory CSV