← Back to catalogue
10THERMA Return Pad
EUDAMEDClass IIb (EU MDR)
Ref TMRP01Model 10THERMA
by TENTECH Inc.
Identity
- Trade Name
- 10THERMA Return Pad EUDAMED
- Device Name
- Electrosurgical Unit EUDAMED
- Model / Reference
- 10THERMA EUDAMEDTMRP01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809709380190 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 Return Pad by TENTECH Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency ablation system.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Cavi di connessione — ADVANCED MEDICAL SYSTEMS GROUP S.R.L. · Class I
- RF Ablation Electrode Kits — SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · Class IIb
- CP-16 TIP — Jeisys Medical Inc. · Class IIb
- Acessa ProVu PFG Table Clamp — ACESSA HEALTH INC. · Class II
- DIAMOND TIP — Jeisys Medical Inc. · Class IIb
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Acessa ProVu System — ACESSA HEALTH INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TENTECH Inc.
- EUDAMED SRN
- KR-MF-000035109
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED 1e46e82f-46bc-4850-a72d-ad030c2ea022 61 fields · synced Jul 30, 2026