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Tentech Co., Ltd.

Active in EUDAMED

Registered as TENTECH Inc. in EUDAMED

South Koreafrom SRN EUDAMED SRN KR-MF-000035109

Part of TENTECH Inc.

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.

Devices
27
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 16
  • EUDAMED 10
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 17
  • EU Class IIb 10
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000035109

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate

What Tentech Co., Ltd. makes

Tentech Co., Ltd. manufactures electrosurgical systems for tissue ablation and intense pulsed light (IPL) devices for skin surface treatments, including systems like the XTHERMA and 10PL series.

Their portfolio consists of Class II medical devices authorised via FDA 510(k) and UDI registrations, with listings maintained in the US regulatory system.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue27

Newest first, rows 1-27 of 27

Search and filter all 27 devices
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  • 10THERMA / Xtherma Tip TMET0.25-300/ XMET0.25-300

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMET0.25-600/ XMET0.25-600

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMFT4.0-600/ XMFT4.0-600

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMFT4.0-900/ XMFT4.0-900

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMFT4.0-300/ XMFT4.0-300

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMFT5.0-300/ XMFT5.0-300

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMFT5.0-600/ XMFT5.0-600

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMFT5.0-900/ XMFT5.0-900

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMBT20.0-1000/ XMBT20.0-1000

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA / Xtherma Tip TMBT20.0-500/ XMBT20.0-500

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Xtherma-H/P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10PL-Body

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA TMHP02

    Active Regimes: 510(k) Registry: GUDID Class:II

  • XTHERMA-Body

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10THERMA TMSY02

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10PL-H/P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 10PL Ref K220794

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 10THERMA Coupling Fluid Ref TMCF01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA Electrode Ref TMET0.25-600

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA Electrode Ref TMFT4.0-600

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA Handpiece Ref TMHP01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA Cooling Gas Ref TMCG01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA Foot Switch Ref TMFS01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA Return Pad Ref TMRP01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA-Bk

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • 10THERMA Electrode Ref TMFT5.0-900

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIb

Rows 1-27 of 27

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000035109
EUDAMED status
Active
EUDAMED registered name
TENTECH Inc.
Registered address
326, Bongeunsa-ro, 06143, Gangnam-gu,, South Korea
Website
tenlaser.com/
Phone
+82 2 6954 2203
PRRC contact
Deokhun Kim(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 11 Nov 2030

EUDAMED certificates (1)

3EC International a.s. 2265 1 certificate

  • 2025-MDR/QS-054/A Active Supplemented

    Quality management system EU MDR

    Issued
    10 Mar 2026
    Expires
    11 Nov 2030
    Reason
    Other

Frequently asked questions

How many devices does Tentech Co., Ltd. have in the registry?

The registry currently lists 27 devices for Tentech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tentech Co., Ltd.'s devices?

Among its 27 most recently registered devices, Tentech Co., Ltd. has devices listed in EUDAMED (10 devices), FDA 510(k) (1 device) and FDA GUDID (16 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Tentech Co., Ltd.'s devices fall under?

Among its 27 most recently registered devices, the classes recorded for Tentech Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Tentech Co., Ltd.?

EUDAMED lists 1 certificate for Tentech Co., Ltd. (quality management system) under MDR. The most recent was issued on 10 Mar 2026.

What are the newest devices from Tentech Co., Ltd. in the registry?

The most recently registered devices listed for Tentech Co., Ltd. include 10THERMA / XTHERMA TIP TMET0.25-300/ XMET0.25-300, 10THERMA / XTHERMA TIP TMET0.25-600/ XMET0.25-600, 10THERMA / XTHERMA TIP TMFT4.0-600/ XMFT4.0-600 and 10THERMA / XTHERMA TIP TMFT4.0-900/ XMFT4.0-900.

Generated automatically from registry data and not verified by a human reviewer.