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10THERMA Handpiece
EUDAMEDClass IIb (EU MDR)
Ref TMHP01Model 10THERMA
by TENTECH Inc.
Identity
- Trade Name
- 10THERMA Handpiece EUDAMED
- Device Name
- Electrosurgical Unit EUDAMED
- Model / Reference
- 10THERMA EUDAMEDTMHP01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809709380220 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
10THERMA Handpiece by TENTECH Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 dcd0eb96-32d5-4568-ba0e-fbb87d54d5dc 61 fields · synced Jun 19, 2026