10THERMA Coupling Fluid
by TENTECH Inc.
Part of a family of 10 devices: see the family page
Ref TMCF01Model 10THERMA
10THERMA Coupling Fluid (TMCF01) is a medical device (EU MDR Class IIb; EMDN category devices for surgery with radiofrequency generator) made by Tentech Co., Ltd., registered in EUDAMED on 12 Nov 2025 (Basic UDI-DI 880970938TMSY03ZR) with CE/MDR certificate 2025-MDR/QS-054/A valid until 11 Nov 2030, active as of 23 Oct 2026.
Active
CE MDR
Valid until
11 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2025-MDR/QS-054/A | Date10 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 880970938TMSY03ZR
Certificates
- 2025-MDR/QS-054/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 10 Mar 2026
- Expires
- 11 Nov 2030
- Reason
- Other
Timeline
- Registered EUDAMED 880970938TMSY03ZR
- Certificate issued EUDAMED 2025-MDR/QS-054/A
- Certificate expires EUDAMED 2025-MDR/QS-054/A
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Electrosurgical Unit
- Model / reference
- 10THERMA, TMCF01
- Primary DI / UDI-DI
- 08809709380183
- Basic UDI-DI
- 880970938TMSY03ZR
- EMDN code
- K020380 Devices for surgery with radiofrequency generator, single-use - accessories
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000035109
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
Similar devices in this category
Other devices filed under DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES.
- RF-DGP-IS by ST. JUDE MEDICAL, INC.
- Palisade™ PG-1020 by Boston Scientific Neuromodulation
- NA TCN-CASE by Boston Scientific Neuromodulation
- POTENZA Tip S-16 by Jeisys Medical Incorporated
- ELLISYS PLUS CWM-930M by Chungwoo Co., Ltd.
- POTENZA Tip I-49 by Jeisys Medical Incorporated
- V-Cure Radiofrequency Electrosurgical Ablation System Generator NONE by Resonant Medical Technology Co., Ltd.
- S-49 Electrode by Jeisys Medical Inc.