OPCOM Medical Inc.
敦揚醫學科技股份有限公司
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1Plants
3Certifications
< NT$20MRevenue band (est.)
- Unified Business No.
- 90215853
- Industry
- Computers, Electronics & Optical Products (2,116)
- Main products
- Audio & video electronics (170)
- Location
- 12 F., No. 6, Jiankang Rd., Zhonghe Dist., New Taipei City 23586, Taiwan (R.O.C.)
New Taipei City (16,829) · Zhonghe Dist. (1,918) - Listing
- Not publicly issued (84,625)
- Organisation type
- Company Limited by Shares
- Representative
- Ting Chih-yu
- Phone
- 02-22217201
- Website
- https://opcommedical.com
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- < NT$20M estimated
- Ownership
- Group subsidiary / corporate-held · Tun Pu Enterprise Co., Ltd.、Ai Mei Te Yi Hsueh Technology Co., Ltd.、Yueh Szu Chuang Yi Co., Ltd.、FORTUNENAMEHOLDLIMITED
- North American market
- FDA 510(k) clearance FDA medical device registration
- Representative tenure
- In office since 2022-03 (4 yrs)
- Compliance record
- Labour Standards Act penalties: 1 case(s) in 5 years, latest 2023-03-29, fines NT$ 20,000 (Art. 30) — matched by company name
Certifications 3
- Medical device license (Class II) (794)Official registry Valid until 2029-12-11 · Taiwan Food and Drug Administration (TFDA)
- FDA (53)Self-reported
- ISO 13485 (310)Self-reported
Processes & materials 8
- Stainless steel (903) · MetalSelf-reported
- Engineering plastics (204) · PolymerSelf-reported
- Injection Molding (497) · FormingSelf-reported
- Bending (188) · FormingSelf-reported
- Extrusion (323) · FormingSelf-reported
- Punching (154) · FormingSelf-reported
- Welding (626) · JoiningSelf-reported
- Laser welding (64) · JoiningSelf-reported
North American market evidence 2
- FDA 510(k) clearance K242699 2025-05-28
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) - FDA medical device registration 3033010858 2024-04-30 – 2026-05-06
Cystoscope And Accessories, Flexible/Rigid; Laryngoscope, Rigid; Endoscopic Video Imaging System/Component, Gastroenterology-Urology and more (6)
Similar companies 10
- Sound Land Corporation · Taoyuan City NT$20–100M estimated
Shared: Injection Molding, Welding, Medical device license (Class II), FDA - BLIKSEN CO., LTD. · Tainan City < NT$20M estimated
Shared: Stainless steel, Injection Molding, Bending, Extrusion - RITEK CORPORATION · Hsinchu County Listed (TWSE) ≥ NT$5B
Shared: Injection Molding, Medical device license (Class II), Other optical instruments & equipment manufacturing n.e.c., Radiation & electromedical equipment manufacturing - HSIN TU TECHNOLOGY CO., LTD. · Taichung City NT$20–100M estimated
Shared: Medical device license (Class II), Other electronic components manufacturing n.e.c., Radiation & electromedical equipment manufacturing - LIGHTMED CORPORATION · New Taipei City < NT$20M estimated
Shared: Medical device license (Class II), Radiation & electromedical equipment manufacturing - COTTAI LTD. · Tainan City NT$20–100M estimated
Shared: Bending, Extrusion, Punching, Welding - Sagen Technology Inc. · Kaohsiung City NT$20–100M estimated
Shared: Other optical instruments & equipment manufacturing n.e.c. - HUEI TYNG ENTERPRISE CO., LTD. · Changhua County NT$100–500M estimated
Shared: Stainless steel, Bending, Punching, Welding - NAVIFUS CORPORATION · Taipei City Listed (TPEx) NT$20–100M
Shared: Medical device license (Class II), FDA, ISO 13485 - SHANG CHEN LASER CO., LTD. · Changhua County NT$20–100M estimated
Shared: Stainless steel, Bending, Welding, Laser welding