Unified Business No.

84279416

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

1 F., No. 16, Ln. 130, 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)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

1993-06-04

Paid-in capital

NT$ 20,000,000

Representative

Lee Chi-jan

Phone

02-82192005

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · HI-CLEARANCE INC.

North American market

FDA 510(k) clearance

Representative tenure

In office since at least 2013 (13+ years)

Plants 2

• Plant · 2F, No. 4, Ln. 130, Minquan Rd., Xindian Dist., New Taipei City↗ In production
• Dianchang) Dianchang · 1F, No. 16, Ln. 130, Minquan Rd., Xindian Dist., New Taipei City↗ In production

Certifications 12

• Medical device license (Class II) (794)Official registry Valid until 2030-01-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-06-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-09-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-02-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-05-01 · Taiwan Food and Drug Administration (TFDA)

North American market evidence 1

• FDA 510(k) clearance K160849 2016-12-15
  WS(TM) Far-Infrared Therapy Unit, Model KP-B210

Similar companies 10

• Pan Asia International Medical Devices CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• GOOD NEWS MEDICAL CO., LTD. · Keelung City < NT$20M estimated
  Shared: Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c., Radiation & electromedical equipment manufacturing
• Huijia Health Corporation · Hsinchu County < NT$20M estimated
  Shared: Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c.
• QT MEDICAL, INC. TAIWAN BRANCH (U.S.A.) · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• SEINOH OPTICAL CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• LIVERAGE BIOMEDICAL INC. · Hsinchu County < NT$20M estimated
  Shared: Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• ZHUO YI TECHNOLOGY CO., LTD. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class II), Radiation & electromedical equipment manufacturing, Medical equipment wholesale
• Accurate Meditech INC. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical equipment wholesale
• TAIWAN BIOPHOTONIC CORPORATION · Hsinchu County < NT$20M estimated
  Shared: Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c., Radiation & electromedical equipment manufacturing
• WINNOMED COMPANY LTD. · Taoyuan City < NT$20M estimated
  Shared: Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c.

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