Unified Business No.

53242203

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

3F., NO.12, SEC. 2, SHENGYI RD., ZHUBEI CITY, HSINCHU COUNTY 302, TAIWAN (R.O.C.)↗
Hsinchu County (1,617) · Zhubei City (468)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Lin Mei-hua

Phone

03-6588129

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Group subsidiary / corporate-held · Huei Chia Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Certifications 25

• Medical device license (Class I) (1,430)Official registry Valid until 2030-03-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-03-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-03-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-03-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-03-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-03-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-03-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-09-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-10-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-07-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-07-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-02-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-02-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-02-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-01-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-08-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-08-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-05-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-02-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-08-06 · Taiwan Food and Drug Administration (TFDA)

Patents 12

• 2024 Vascular clip applying device with locking structure
• 2024 Surgical clip applier and handle portion thereof
• 2024 Surgical clip applier

North American market evidence 10

• FDA 510(k) clearance K252535 2026-08-25
  Inno-Switch™ Laparoscopic Instruments
• FDA 510(k) clearance K254231 2026-07-20
  Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips
• FDA 510(k) clearance K252532 2026-06-02
  Inno-Port Disposable Bladed Trocar
• FDA 510(k) clearance K253781 2025-12-22
  InnoClip Clip Applier
• FDA 510(k) clearance K253903 2025-12-22
  InnoClip Disposable Clip Applier
• FDA 510(k) clearance K223593 2023-03-22
  Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
• FDA 510(k) clearance K202994 2022-01-04
  InnoClip Disposable Clip Applier, InnoClip Clip Applier
• FDA 510(k) clearance K150259 2015-11-06
  CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L
• FDA 510(k) clearance K150253 2015-04-01
  Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
• FDA medical device registration 3010605922 2013-11-14 – 2026-07-21
  Applier, Surgical, Clip; Clip, Implantable; Laparoscope, General & Plastic Surgery and more (6)

Similar companies 10

• Pan Asia International Medical Devices CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Medical equipment wholesale
• LARGAN MEDICAL CO., LTD. · Taichung City NT$1–5B estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other optical instruments & equipment manufacturing n.e.c., Medical equipment wholesale
• SCIENCE TRAINING ENTERPRISE CORP. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other merchandise wholesale brokerage n.e.c., Medical equipment wholesale
• AEON BIOTHERAPEUTICS CORP. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other optical instruments & equipment manufacturing n.e.c., Medical equipment wholesale
• TSUKOSHI INDUSTRIAL CORP. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), Other merchandise wholesale brokerage n.e.c., Medical equipment wholesale
• WINNOMED COMPANY LTD. · Taoyuan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c.
• TAIWAN ONP COMPANY · Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c.
• OSSAWARE BIOTECH CO., LTD. · Changhua County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other optical instruments & equipment manufacturing n.e.c.
• Faciox Inc. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical equipment wholesale
• NANOSIGMA BIOTECH. CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical equipment wholesale

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