Marktintelligenz

South Korea

Medizinprodukt-Marktintelligenz für South Korea. Regulatorische Änderungen, Wettbewerber und Beschaffungstrends.

121
Signals / 7 days
228
Activity Score
MFDS
KGMP · Medical Device Approval

Neueste Signale

com_launch2026-06-04

A study is recruiting 100 patients to evaluate the CART-BP ring-type blood pressure device against 24-hour ABPM in HFrEF.

ClinicalTrials.gov · 2025-10-23
reg_registration2026-06-01

SKIA has received FDA 510(k) clearance for its AR surgical guidance system, SKIA HEAD.

Medical Device Network · 2026-06-01
reg_registration2026-06-01

Taewoong Medical's ComVi Pyloric/Duodenal Stent is classified as Class IIB and registered in EUDAMED.

EUDAMED EU Device Database ·
reg_registration2026-06-01

Taewoong Medical's ComVi Pyloric/Duodenal Stent is classified as Class IIB medical device.

EUDAMED EU Device Database ·
reg_registration2026-06-01

Taewoong Medical's ComVi Pyloric/Duodenal Stent is classified as Class IIB and registered in EUDAMED.

EUDAMED EU Device Database ·
reg_registration2026-05-25

KOREA OGK CO., LTD. has registered a medical device with the FDA under product code LYU.

FDA Device Registration & Listing ·
reg_registration2026-05-25

Sentech Korea Corp has registered a medical device with the FDA under product code DJZ.

FDA Device Registration & Listing ·
com_launch2026-05-18

A study on a wearable hip assist robot for gait rehabilitation in stroke patients and elderly adults has been completed.

ClinicalTrials.gov · 2016-01-02
com_launch2026-05-18

A study on wearable passive back support suits shows potential in reducing back pain for caregivers during patient transport.

ClinicalTrials.gov · 2025-03-21
com_launch2026-05-15

A study evaluated the efficacy and safety of the NeoSculpt monopolar radiofrequency device for facial rejuvenation.

ClinicalTrials.gov · 2025-01-01
com_launch2026-05-15

A study evaluated a fractional radiofrequency device for submental fat reduction, sponsored by Seoul National University.

ClinicalTrials.gov · 2021-06-07
com_launch2026-05-15

The study evaluates the L'DISQ device for lumbar disc herniation treatment outcomes.

ClinicalTrials.gov · 2009-03-01
reg_enforcement2026-05-15

A clinical trial is recruiting to evaluate the AIIV L2 device's efficacy in venipuncture compared to manual methods.

ClinicalTrials.gov · 2026-01-26
reg_enforcement2026-05-12

The clinical trial for the Zenicom device aims to evaluate its safety and efficacy for stroke-related aphasia.

ClinicalTrials.gov · 2025-12-10
com_launch2026-05-12

A feasibility study evaluates a new biopsy track ablation device for liver biopsy safety and effectiveness.

ClinicalTrials.gov · 2015-09-01
reg_registration2026-05-12

HANIL MEDICAL CO., LTD. has registered a medical device with FDA under product code ISA.

FDA Device Registration & Listing ·
reg_registration2026-05-12

Korea Optical Co., Ltd. has FDA registration 9615929 for product code HQG, listing one medical device.

FDA Device Registration & Listing ·
com_launch2026-05-08

A study evaluated a portable pressure measuring device for garment therapy on hypertrophic scars, comparing it to PicoPress®.

ClinicalTrials.gov · 2020-06-10
com_launch2026-05-08

A study completed by Asan Medical Center shows wearable devices effectively monitor distress in breast cancer survivors.

ClinicalTrials.gov · 2017-06-13
com_launch2026-05-07

A study on a ring-type wearable device for detecting atrial fibrillation is underway at Seoul National University Hospital.

ClinicalTrials.gov · 2018-01-23

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