Unified Business No.

91066557

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

2 F., No. 43, Zhongxing Rd., Xizhi Dist., New Taipei City 221012, Taiwan (R.O.C.)↗
New Taipei City (16,829) · Xizhi Dist. (1,300)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2021-08-20

Paid-in capital

NT$ 16,100,000

Representative

Chen Chung-peng

Phone

02-8646-1999

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Individually held

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2021-08 (5 yrs)

Plants 2

• Plant · 2F, No. 43, Zhongxing Rd., Xizhi Dist., New Taipei City↗ In production
• Nanxing Plant · 2, 3, 4F, No. 58, Nanxing Rd., Xizhi Dist., New Taipei City↗ In production

Certifications 16

• Medical device license (Class I) (1,430)Official registry Valid until 2028-04-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-04-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-02-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-03-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-04-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-05-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-08-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-09-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-04-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-12-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-03-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-08 · Taiwan Food and Drug Administration (TFDA)

Processes & materials 1

• Medical devices (32) · Company nameSelf-reported

North American market evidence 4

• FDA 510(k) clearance K252260 2025-11-26
  RELIEEV HSG Catheter (HSG7FA1)
• FDA 510(k) clearance K240364 2024-10-16
  RELIEEV Uterine Manipulator Injector (CUMI 5.0)
• FDA 510(k) clearance K240434 2024-09-25
  RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
• FDA medical device registration 3025325116 2022-10-16 – 2025-12-10
  Cannula, Manipulator/Injector, Uterine; Sound, Uterine; Pessary, Vaginal and more (6)

Similar companies 10

• Ace Medical Technology Co., Ltd. · Taoyuan City < NT$20M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II)
• Yang Cheng Medical Co., Ltd. · Taichung City < NT$20M estimated
  Shared: Medical devices, Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• UNIK SURGICAL SUTURES MFG. CO. · New Taipei City NT$100–500M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• FORTUNE MEDICAL INSTRUMENT CORP. · Taoyuan City NT$100–500M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• EIKON HEALTHCARE DEVICE CORP. · New Taipei City NT$20–100M estimated
  Shared: Medical devices, Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• TAIWAN BIOMATERIAL COMPANY LIMITED · Hsinchu County Listed (TPEx) NT$100–500M
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• CHANG HONG MEDICAL TECHNOLOGY INC. · Changhua County < NT$20M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II)
• Fu Lin Fu Chu Yi Tsai Co., Ltd. · Kaohsiung City < NT$20M estimated
  Shared: Medical devices, Other medical devices & supplies manufacturing n.e.c.
• GREAT GROUP MEDICAL CO., LTD. · Changhua County < NT$20M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• CelerMed Biomaterial CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical devices, Other medical devices & supplies manufacturing n.e.c.

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