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10THERMA Foot Switch
EUDAMEDClass IIb (EU MDR)
Ref TMFS01Model 10THERMA
by TENTECH Inc.
Identity
- Trade Name
- 10THERMA Foot Switch EUDAMED
- Device Name
- Electrosurgical Unit EUDAMED
- Model / Reference
- 10THERMA EUDAMEDTMFS01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809709380237 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 Foot Switch by TENTECH Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 2cb15339-1819-4e4e-9eba-2ef57f07a9ff 61 fields · synced Jul 12, 2026