Unified Business No.

53412591

Industry

Textiles (2,939)

Main products

Textile products (1,300)

Location

No. 55, Aly. 51, Ln. 50, Daren Rd., Dalin Vil., Taoyuan Dist., Taoyuan City 330058, 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

2011-05-30

Paid-in capital

NT$ 140,000,000

Representative

Chen Yung-chih

Phone

03-3637999

Website

https://taiwan-champ.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Family-run (inferred)

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2016 (10+ years)

Compliance record

FDA import refusal: 3 product(s), latest 2021-09-17

Plants 2

• Dechang Plant · No. 270, Dechang St., Yingge Dist., New Taipei City↗ In production
• Taoyuan Plant · No. 55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City↗ In production

Certifications 29

• Medical device license (Class I) (1,430)Official registry Valid until 2027-07-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-05-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-07-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-07-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-09-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-07-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-11-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-11-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-01-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-06-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-02-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-02-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-02-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-02-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-04-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-07-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-07-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-12-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-07-27 · Taiwan Food and Drug Administration (TFDA)
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Processes & materials 1

• Cleanroom production (392) · Assembly & inspectionSelf-reported

Patents 7

• 2022 Gas-filtering conditioning mask
• 2021 Protective face shield
• 2021 Multifunctional mask for random application

North American market evidence 3

• FDA 510(k) clearance K212863 2022-02-19
  Surgical Face Mask
• FDA medical device registration 3016734135 2020-04-08 – 2022-09-14
  Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua; Mask, Surgical; Accessory, Surgical Apparel
• FDA import refusal 3016734135 2020-08-17 – 2021-09-17
  MASK, SURGICAL; RESPIRATOR, N95, HOME USE; FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE

Similar companies 10

• WELSON LI CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Cleanroom production, Medical device license (Class I), Medical device license (Class II), ISO 13485
• ASIATIC FIBER CORPORATION · Taoyuan City NT$20–100M estimated
  Shared: Cleanroom production, Medical device license (Class I), Medical device license (Class II), GMP
• ACME FILTER MASK, INC. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, 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
• UNIVERSAL INCORPORATION · Tainan City Listed (TWSE) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), ISO 13485, Non-woven fabric manufacturing
• CareMax Biomedical Co.,Ltd. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), GMP, ISO 13485, Non-woven fabric manufacturing
• AERO PRO CO., LTD. · Changhua County NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), ISO 13485, Non-woven fabric manufacturing
• ANSUS BIOTECH CO., LTD. · Changhua County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Non-woven fabric manufacturing
• MEDLIGHT ENTERPRISE CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II)
• YAW HSUENN ENTERPRISE CO., LTD. · Miaoli County < NT$20M estimated
  Shared: Non-woven fabric manufacturing, Other fabric weaving n.e.c.

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