# Tentech Co., Ltd.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Tentech Co., Ltd. is a medical device manufacturer based in South Korea, with 27 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb) as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/tentech-co-ltd>
- Registered in EUDAMED as: TENTECH Inc.
- Country: South Korea (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer, Part of a group
- Registrations: EUDAMED
- EUDAMED SRN: KR-MF-000035109

## Figures

- Devices: 27
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 16, EUDAMED 10, FDA 510(k) 1
- Device classes: FDA Class II 17, EU Class IIb 10
- EMDN [K02 Electrosurgery devices, single-use](https://devicerts.com/categories/emdn/K02): 10 devices

## Sites and related companies

- Part of [TENTECH Inc.](https://devicerts.com/manufacturers/tentech-inc)

## Devices

The first 27 of 27, in the order of the canonical page, which lists them all.

- [10THERMA / Xtherma Tip TMET0.25-300/ XMET0.25-300](https://devicerts.com/devices/10therma-xtherma-tip-tmet0-25-300-xmet0-25-300) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMET0.25-600/ XMET0.25-600](https://devicerts.com/devices/10therma-xtherma-tip-tmet0-25-600-xmet0-25-600) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMFT4.0-600/ XMFT4.0-600](https://devicerts.com/devices/10therma-xtherma-tip-tmft4-0-600-xmft4-0-600) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMFT4.0-900/ XMFT4.0-900](https://devicerts.com/devices/10therma-xtherma-tip-tmft4-0-900-xmft4-0-900) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMFT4.0-300/ XMFT4.0-300](https://devicerts.com/devices/10therma-xtherma-tip-tmft4-0-300-xmft4-0-300) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMFT5.0-300/ XMFT5.0-300](https://devicerts.com/devices/10therma-xtherma-tip-tmft5-0-300-xmft5-0-300) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMFT5.0-600/ XMFT5.0-600](https://devicerts.com/devices/10therma-xtherma-tip-tmft5-0-600-xmft5-0-600) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMFT5.0-900/ XMFT5.0-900](https://devicerts.com/devices/10therma-xtherma-tip-tmft5-0-900-xmft5-0-900) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMBT20.0-1000/ XMBT20.0-1000](https://devicerts.com/devices/10therma-xtherma-tip-tmbt20-0-1000-xmbt20-0-1000) · Class II · GUDID · status: Active
- [10THERMA / Xtherma Tip TMBT20.0-500/ XMBT20.0-500](https://devicerts.com/devices/10therma-xtherma-tip-tmbt20-0-500-xmbt20-0-500) · Class II · GUDID · status: Active
- [Xtherma-H/P](https://devicerts.com/devices/xtherma-xtherma-h-p) · Class II · GUDID · status: Active
- [10PL-Body](https://devicerts.com/devices/10pl-10pl-body) · Class II · GUDID · status: Active
- [10THERMA TMHP02](https://devicerts.com/devices/10therma-tmhp02) · Class II · GUDID · status: Active
- [XTHERMA-Body](https://devicerts.com/devices/xtherma-xtherma-body) · Class II · GUDID · status: Active
- [10THERMA TMSY02](https://devicerts.com/devices/10therma-tmsy02) · Class II · GUDID · status: Active
- [10PL-H/P](https://devicerts.com/devices/10pl-10pl-h-p) · Class II · GUDID · status: Active
- [10PL](https://devicerts.com/devices/10pl-onf) · ref K220794 · Class II · 510(k) · status: Active · decision 2022-11-10
- [10THERMA Coupling Fluid](https://devicerts.com/devices/10therma-coupling-fluid-tmcf01) · ref TMCF01 · Class IIb · EUDAMED · status: Active
- [10THERMA Electrode](https://devicerts.com/devices/10therma-electrode-tmet0-25-600) · ref TMET0.25-600 · Class IIb · EUDAMED · status: Active
- [10THERMA Electrode](https://devicerts.com/devices/10therma-electrode-tmft4-0-600) · ref TMFT4.0-600 · Class IIb · EUDAMED · status: Active
- [10THERMA Handpiece](https://devicerts.com/devices/10therma-handpiece-tmhp01) · ref TMHP01 · Class IIb · EUDAMED · status: Active
- [10THERMA Cooling Gas](https://devicerts.com/devices/10therma-cooling-gas-tmcg01) · ref TMCG01 · Class IIb · EUDAMED · status: Active
- [10THERMA Foot Switch](https://devicerts.com/devices/10therma-foot-switch-tmfs01) · ref TMFS01 · Class IIb · EUDAMED · status: Active
- [10THERMA](https://devicerts.com/devices/10therma-10therma) · Class IIb · EUDAMED · status: Active
- [10THERMA Return Pad](https://devicerts.com/devices/10therma-return-pad-tmrp01) · ref TMRP01 · Class IIb · EUDAMED · status: Active
- [10THERMA-Bk](https://devicerts.com/devices/10therma-bk-10therma-bk) · Class IIb · EUDAMED · status: Active
- [10THERMA Electrode](https://devicerts.com/devices/10therma-electrode-tmft5-0-900) · ref TMFT5.0-900 · Class IIb · EUDAMED · status: Active

## EU certificates

- 2025-MDR/QS-054/A · Quality management system · MDR · notified body 3EC International a.s. · issued 2026-03-10 · expires 2030-11-11 · status: supplemented

## Source and citation

- Cite as: Tentech Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/tentech-co-ltd (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/tentech-co-ltd.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/tentech-co-ltd
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.