Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

10THERMA Electrode

UDI-DI 08809709380107Basic UDI-DI 880970938TMSY03ZR

Class IIb · MDR · TENTECH Inc.

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Identification

Model: 10THERMA
EMDN: K020380
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2025-MDR/QS-054/A

EU quality management system · unknown

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

Valid from 2026-03-10 · Expiry 2030-11-11

Scope not stated in certificate data.

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

Manufacturer

SRN KR-MF-000035109

KR · Gangnam-gu,

manufacturer

Authorised representative: Javitech Consulting GmbH (DE-AR-000045915)

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10THERMA-BK 08809709381142
10THERMA Cooling Gas 08809709380244
10THERMA Coupling Fluid 08809709380183
10THERMA Electrode 08809709380138
10THERMA Electrode 08809709380114
10THERMA Electrode 08809709380169
10THERMA Electrode 08809709380121
10THERMA Electrode 08809709380091
10THERMA Electrode 08809709380145
10THERMA Electrode 08809709380176
10THERMA Electrode 08809709380329

Showing 12 of 16 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/10therma-electrode-0107 · UDI page: /udi/08809709380107

All devices from TENTECH Inc.

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