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10THERMA Electrode
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref TMFT5.0-900Model 10THERMARef TMFT4.0-300Ref TMBT20.0-500Ref TMBT20.0-1000Ref TMFT4.0-900Ref TMFT5.0-600Ref TMFT5.0-300Ref TMET0.25-300
by TENTECH Inc.
Identity
- Trade Name
- 10THERMA Electrode EUDAMED
- Device Name
- Electrosurgical Unit EUDAMED
- Model / Reference
- 10THERMA EUDAMEDTMFT5.0-900 EUDAMEDTMFT4.0-300 EUDAMEDTMBT20.0-500 EUDAMEDTMBT20.0-1000 EUDAMEDTMFT4.0-900 EUDAMEDTMFT5.0-600 EUDAMEDTMFT5.0-300 EUDAMEDTMET0.25-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809709380169 EUDAMED08809709380107 EUDAMED08809709380176 EUDAMED08809709380329 EUDAMED08809709380121 EUDAMED08809709380145 EUDAMED08809709380138 EUDAMED08809709380091 EUDAMED
- Basic UDI-DI
- 880970938TMSY03ZR EUDAMED
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Radio-frequency ablation system
10THERMA Electrode by TENTECH Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232992 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880970938TMSY03ZR | Class IIb | Active |
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Manufacturer
- Manufacturer
- TENTECH Inc.
- EUDAMED SRN
- KR-MF-000035109
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (9)
- EUDAMED 38acf2e1-4ea6-45c0-b770-5b18d3b06155 61 fields · synced Sep 17, 2026
- EUDAMED 1b23ce83-2d48-4b80-93a1-1930c6b05a7f 61 fields · synced May 17, 2026
- EUDAMED d53183d7-1626-4592-b3c7-bd84e6cfd5bf 61 fields · synced May 17, 2026
- EUDAMED bd3f4ba2-2649-4472-8d4f-cee16a471ca7 61 fields · synced May 17, 2026
- EUDAMED 966b689f-ff5c-4838-8113-ae6b6623fd9c 61 fields · synced May 17, 2026
- EUDAMED 5a79dac7-c8c3-4586-98b5-c5c127fa79ae 61 fields · synced May 18, 2026
- EUDAMED 797e838d-ef00-424d-ba00-9e69753ae56c 61 fields · synced May 18, 2026
- EUDAMED 6de13ad4-0515-4b06-b76c-17142c8006eb 61 fields · synced May 18, 2026
- FDA 510(k) K232992 1 fields · synced May 18, 2026