Unified Business No.

42755937

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

2 F., No. 21, Shuili Rd., Qianjia Vil., East Dist., Hsinchu City 300053, Taiwan (R.O.C.)↗
Hsinchu City (1,019) · East Dist. (401)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Kung Tsung-ching

Phone

03-5752910

Website

https://www.apexlens.com/en/Index

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · Cheng Fu Tou Tzu Co., Ltd.、Chih Yuan Tou Tzu Co., Ltd.

Representative tenure

In office since 2024-07 (2 yrs); last handover 2024-07

Compliance record

FDA import refusal: 1 product(s), latest 2022-01-12

Certifications 10

• Medical device license (Class II) (794)Official registry Valid until 2027-09-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-04-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-04-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-04-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-07-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-07-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-07-03 · Taiwan Food and Drug Administration (TFDA)
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Processes & materials 2

• Rubber & silicone (739) · PolymerSelf-reported
• Casting (638) · FormingSelf-reported

Patents 3

• 2023 Contact lens with multifunctional point
• 2022 Myopia control contact lens
• 2022 Positioning structure for contact lens

North American market evidence 1

• FDA import refusal 3021174300 2022-01-12
  LENS, CONTACT (DISPOSABLE)

Similar companies 10

• PEGAVISION CORPORATION · Taoyuan City Listed (TWSE) ≥ NT$5B
  Shared: Rubber & silicone, Medical device license (Class II), GMP, ISO 13485
• HMD BIOMEDICAL INC. · Hsinchu County Public company (unlisted) NT$100–500M
  Shared: Medical device license (Class II), GMP, ISO 13485, Other medical devices & supplies manufacturing n.e.c.
• ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
  Shared: Medical device license (Class II), GMP, ISO 13485, Other medical devices & supplies manufacturing n.e.c.
• 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
• MARIA VON MED-BIOTECHNOLOGY CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), GMP, ISO 13485, Other medical devices & supplies manufacturing n.e.c.
• 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
• GOLDEN SMART HOME TECHNOLOGY CORP. · Hsinchu City NT$100–500M estimated
  Shared: Medical device license (Class II), GMP, ISO 13485, Other medical devices & supplies manufacturing n.e.c.
• OMNIMATE ENTERPRISE CO., LTD. · Yilan County < NT$20M estimated
  Shared: Rubber & silicone, Medical device license (Class II), GMP, ISO 13485
• 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
• SANGTECH LAB INC. · Taipei City < NT$20M estimated
  Shared: Medical device license (Class II), GMP, ISO 13485

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