MEDTECS (TAIWAN) CORP.

Unified Business No.

70541649

Industry

Apparel & Accessories (961)

Main products

Apparel (729)

Location

11 F., No. 9, Songgao Rd., Xinyi Dist., Taipei City 110206, Taiwan (R.O.C.)↗
Yilan County (1,016) · Dongshan Township (231)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2000-03-27

Paid-in capital

NT$ 250,000,000

Representative

Chen Su-tien

Phone

02-27392222

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Foreign-owned · Bermuda · Pai Mu Ta Shang Mei Te Hsieng Pang Yi Liao International Co., Ltd.

North American market

FDA 510(k) clearance

Representative tenure

In office since 2018-05 (8 yrs); last handover 2018-05

Compliance record

Environmental penalties: 1 case(s) in 5 years, latest 2022-01-11, fines NT$ 105,000 (water pollution)
Labour Standards Act penalties: 6 case(s) in 5 years, latest 2026-06-30, fines NT$ 230,000 (Art. 32; Art. 24; Art. 30) — matched by company name

Plants 2

• Yilan Plant · No. 18, Dexing 4th Rd., Dongshan Township, Yilan County↗ In production
• Xiangshan Plant · No. 2, Guanyizhi Guanyi, Zhunan Township, Miaoli County↗ In production

Certifications 45

• Medical device license (188)Official registry Valid until 2010-10-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2011-05-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-11-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-11-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-01-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-11-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-01-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-02-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-05-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-09-16 · 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 2030-11-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-12-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-08-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-03-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-08-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-11-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-05-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-03-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-10-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-10-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-04-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-04-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-12-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-12-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-08-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-08-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-04-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-11-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-09-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-03-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-08-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-04-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-04-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-11-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-24 · Taiwan Food and Drug Administration (TFDA)

Patents 2

• 2019 V-shaped pillow structure
• 2019 L-shaped pillow structure

North American market evidence 2

• FDA 510(k) clearance K210414 2022-10-21
  CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
• FDA 510(k) clearance K203376 2022-03-02
  ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G

Recent changes 8

• 2026-11-10
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2026-11-10
• 2026-10-31
  Certification expiryMedical device license (Class II) certificate expired on 2026-10-31
• 2026-08-27
  Certification expiryMedical device license (Class I) certificate expired on 2026-08-27
• 2026-06-30
  PenaltiesLabour Standards Act penalties: latest case 2026-06-30; 6 case(s) in 5 years, fines NT$ 230,000
• 2026-04-15
  Certification expiryMedical device license (Class I) certificate expired on 2026-04-15
• 2026-04-14
  Certification expiryMedical device license (Class I) certificate expired on 2026-04-14
• 2026-03-17
  Certification expiryMedical device license (Class II) certificate expired on 2026-03-17
• 2025-12-31
  Certification expiryMedical device license (Class I) certificate expired on 2025-12-31

RSS feed · Recent changes at Taiwanese manufacturers →

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