Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

10THERMA Coupling Fluid

UDI-DI 08809709380183Basic 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 Electrode 08809709380138
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10THERMA Electrode 08809709380169
10THERMA Electrode 08809709380121
10THERMA Electrode 08809709380091
10THERMA Electrode 08809709380145
10THERMA Electrode 08809709380176
10THERMA Electrode 08809709380329
10THERMA Electrode 08809709380107

Showing 12 of 16 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/10therma-coupling-fluid-0183 · UDI page: /udi/08809709380183

All devices from TENTECH Inc.

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