NEWS

Title Tentech Inc. Secures Overseas Certifications for 10THERMA and 10THERA, Enhancing Global Market Reach
Tentech Inc., a global medical device manufacturer, is enhancing the competitive power of its products in the worldwide market.

According to Tentech Inc., it received medical device certification for ‘10THERMA’ from the Medical Device Authority (MDA) of Malaysia on the 13th, followed by certification for ‘10THERA’ from the Therapeutic Goods Administration (TGA) of Australia on the 14th.


10THERMA (400W, 6.78MHz) is an MRF (monopolar radiofrequency) treatment device that can deliver RF energy to the dermis, generating heat through the skin's electrical resistance. The 5㎠ face tip of 10THERMA is wider than other RF devices, allowing for 20% more energy coverage per shot. 10THERMA is equipped with impedance matching technology that helps adjust precise targeted energy for individuals.

Tentech Inc. has quickly obtained certifications for 10THERMA from global countries such as the United States (U.S. FDA), Taiwan (TFDA), Vietnam (MoH), Indonesia (MoH), and Thailand (TFDA).

10THERA, using the principle of High Intensity Focused Ultrasound (HIFU), is a HIFU treatment device that delivers ultrasound heat energy to the targeted area. By delivering high heat to the targeted area, typically the SMAS layer or the dermis, it can stimulate the production of collagen. The 10THERA applicator is composed of 2 lines, contributing to a shorter procedure time.

Tentech Inc. has obtained certifications for 10THERA from various oversea countries including Europe (CE), Taiwan (TFDA), Vietnam (MoH), Indonesia (MoH), Thailand (TFDA), Saudi Arabia (SFDA), and the UAE (MoH).


A representative for Tentech Inc. said, “We recently conducted launch events for products in the countries where certifications for products were approved” and he added, “Tentech's movements to expand in the global market are expected to result in increased overseas sales this year.”

Hits # 308 Date 2024.05.20

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