Unified Business No.

22244310

Industry

Textiles (2,939)

Main products

Non-woven fabrics (120)

Location

1 F., No. 57, Hushan Rd., Yingge Dist., New Taipei City 23941, Taiwan (R.O.C.)↗
New Taipei City (16,829) · Yingge Dist. (571)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

1986-09-02

Paid-in capital

NT$ 46,500,000

Representative

Chen Min-yun

Phone

02-2678-9377

Website

https://www.acmemask.com/mobile/about.php?id=1

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 at least 2013 (13+ years)

Compliance record

Environmental penalties: 3 case(s) in 5 years, latest 2022-01-07, fines NT$ 132,000 (stationary air pollution; industrial waste)
Occupational safety penalties: 2 case(s) in 5 years, latest 2025-05-19, fines NT$ 80,000 (Art. 12; Art. 6) — matched by company name

Plants 2

• Plant · 1F, No. 57, Hushan Rd., Yingge Dist., New Taipei City↗ In production
• Plant 2 · No. 49, Ln. 658, Yingtao Rd., Yingge Dist., New Taipei City↗ In production

Certifications 15

• Medical device license (Class I) (1,430)Official registry Valid until 2029-10-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-05-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-01-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-04-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-09-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-02-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-05-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2012-11-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-08-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-12-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-01-21 · Taiwan Food and Drug Administration (TFDA)
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported
• ISO 9001 (4,293)Self-reported

North American market evidence 2

• FDA 510(k) clearance K123115 2013-05-20
  ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
• FDA medical device registration 3007053183 2020-03-10 – 2020-12-17
  Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua; Accessory, Surgical Apparel; Mask, Surgical

Similar companies 10

• UNIVERSAL INCORPORATION · Tainan City Listed (TWSE) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), ISO 13485
• NAN LIU ENTERPRISE CO., LTD. · Kaohsiung City Listed (TWSE) ≥ NT$5B
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• AERO PRO CO., LTD. · Changhua County NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), ISO 13485, Other finished textile products manufacturing n.e.c.
• LIH YOW ENTERPRISE CO., LTD. · Changhua County NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• Jingxin Technology Co., Ltd. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other finished textile products manufacturing n.e.c., Other medical devices & supplies manufacturing n.e.c.
• CHANG HSIN BIOTECH CO., LTD. · Changhua County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• GRAMINTON ENTERPRISE LTD. · Taichung City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II)
• YIXING CO. · Taichung City NT$20–100M estimated
  Shared: Other finished textile products manufacturing n.e.c.
• TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• INFINA TECHNOLOGY CO., LTD. · Taoyuan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, Other medical devices & supplies manufacturing n.e.c.

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