Unified Business No.

65445701

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

12F.-9, No. 51, Sec. 4, Zhongyang Rd., Tucheng Dist., New Taipei City 23675, Taiwan (R.O.C.)↗
Chiayi County (1,525) · Lucao Township (37)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2016-09-07

Paid-in capital

NT$ 500,000,000

Representative

Liu Huei-chen

Phone

02-22681726

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · Kuang Hsing Chien Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration Health Canada medical device licence

Representative tenure

In office since 2016-09 (10 yrs)

Plants 2

• Chiayi Plant · No. 16, Houyuanqu Houyuan 1st Rd., Lucao Township, Chiayi County↗ In production
• Plant · 9F-9~-12, 10F, 10F-2~-3, 10F-5~-12, 11F, 11F-2~-3, 11F-5~-12, 9F, No. 51, Sec. 4, Zhongyang Rd., Tucheng Dist., New Taipei City↗ In production

Certifications 10

• Medical device license (188)Official registry Valid until 2013-11-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2009-03-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-08-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2013-08-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2013-10-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2013-10-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2011-08-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2011-11-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-01-22 · Taiwan Food and Drug Administration (TFDA)

Patents 1

• 2021 Smoke-absorbing electrosurgical knife

North American market evidence 16

• FDA 510(k) clearance K251492 2026-06-29
  Irrigation Tubing Bipolar Cord Set
• FDA 510(k) clearance K251899 2025-10-01
  E Blator
• FDA 510(k) clearance K202962 2020-11-20
  Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft
• FDA 510(k) clearance K201221 2020-09-28
  Electrosurgical Generator
• FDA 510(k) clearance K200455 2020-03-31
  Trigger Switch and Cord
• FDA 510(k) clearance K193004 2019-12-19
  Monopolar Cord
• FDA 510(k) clearance K191064 2019-06-12
  Argon Handset
• FDA 510(k) clearance K183126 2019-05-08
  Electrosurgical accessory
• FDA 510(k) clearance K183594 2019-02-19
  Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J
• FDA 510(k) clearance K180908 2018-05-18
  Irrigation Tubing Bipolar Cord Set
• FDA 510(k) clearance K170161 2017-03-29
  New Deantronics E Green™ Electrosurgical Monopolar Pencils
• FDA 510(k) clearance K153265 2016-01-05
  New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
• FDA 510(k) clearance K152031 2015-09-17
  New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
• FDA medical device registration 9681191 2007-12-20 – 2026-06-17
  Electrosurgical, Cutting & Coagulation & Accessories; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Software For Diagnosis/Treatment and more (13)
• FDA medical device registration 3016099036 2011-10-10 – 2025-06-23
  Electrosurgical, Cutting & Coagulation & Accessories; Orthopedic Manual Surgical Instrument; Arthroscope and more (4)
• Health Canada medical device licence 117049

Similar companies 10

• UNITED ORTHOPEDIC CORPORATION · Hsinchu City Listed (TPEx) ≥ NT$5B
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• GALEMED CORPORATION · Yilan County NT$100–500M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• Lien Sheng Yi Liao Wei Tsai Co., Ltd. · Changhua County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• BIOTECH ONE INC. · Hsinchu County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• YI LIN ENTERPRISE CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• TENNYSON MEDICAL INSTRUMENT DEVELOPING CO. · Changhua County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• SHINING WORLD HEALTH CARE CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• PERFECT MEDICAL INDUSTRY CO., LTD. · Changhua County Emerging stock (TPEx) NT$0.5–1B
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• CONPLUS INTERNATIONAL CO., LTD. · New Taipei City NT$100–500M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• NEOASIA LTD. · Taipei City NT$100–500M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.

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