Unified Business No.

27449663

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

5 F., No. 46-4, Minquan Rd., Xindian Dist., New Taipei City 231023, Taiwan (R.O.C.)↗
New Taipei City (16,829) · Xindian Dist. (687)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Chang Kuo-yuan

Phone

02-29182390

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · Kuang Ta Chuang Yeh Tou Tzu Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2014 (12+ years)

Certifications 8

• Medical device license (Class II) (794)Official registry Valid until 2028-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-12-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-12-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-09-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2017-01-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-13 · Taiwan Food and Drug Administration (TFDA)

North American market evidence 3

• FDA 510(k) clearance K112269 2011-10-20
  OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
• FDA 510(k) clearance K050680 2005-05-13
  BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7
• FDA medical device registration 3004918630 2008-01-25 – 2012-02-09
  System, Measurement, Blood-Pressure, Non-Invasive

Similar companies 10

• CROWN PORCELAIN DENTAL TECHNOLOGY CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II)
• LIGHTMED DENTAL TECHNOLOGY CORPORATION · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class II)
• MEDSTAR INTERNATIONAL INC. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class II), Other household appliances wholesale n.e.c.
• TSUKOSHI INDUSTRIAL CORP. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), Other merchandise wholesale brokerage n.e.c.
• GOOD HARVEST TECHNOLOGY CO., LTD. · Miaoli County < NT$20M estimated
  Shared: Medical device license (Class II)
• FOUNTAIN MEDICAL EQUIPMENTS CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II)
• WELLMIKE TECHNOLOGY CORPORATION · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II)
• HONG SHIANG TECHNOLOGY CO., LTD. · Tainan City < NT$20M estimated
  Shared: Medical device license (Class II), Electronic equipment wholesale
• ROWWIN INTERNATIONAL CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class II)
• Leah dental CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II)

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