10THERMA
by TENTECH Inc.
Part of a family of 10 devices: see the family page
Ref 10THERMA
10THERMA 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- Withdrawn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
- Primary DI / UDI-DI
- 08809709380374
- 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
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