HOME CARE TECHNOLOGY CO., LTD.

Unified Business No.

84156977

Industry

Other Manufacturing (2,432)

Main products

Other manufactured products n.e.c. (841)

Location

1 F., No. 14, Ln. 20, Guangdong Rd., Pingzhen Dist., Taoyuan City 32447, Taiwan (R.O.C.)↗
Tainan City (8,491) · Rende Dist. (1,143)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Limited Company

Founded

1993-01-08

Paid-in capital

NT$ 28,500,000

Representative

Chou Huei-ling

Phone

06-2724880

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Individually held

North American market

FDA 510(k) clearance FDA medical device registration Health Canada medical device licence

Representative tenure

In office since at least 2015 (10+ years)

Compliance record

FDA import refusal: 1 product(s), latest 2021-05-27

Plants 3

• Plant 3 · No. 39, 43, 47, Dali Rd., Rende Dist., Tainan City↗ In production
• Plant 2 · No. 118, Ln. 523, Sec. 3, Zhongzheng Rd., Rende Dist., Tainan City↗ In production
• Rende Plant · No. 116, Ln. 523, Sec. 3, Zhongzheng Rd., Rende Dist., Tainan City↗ In production

Certifications 28

• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-12-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-11-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-11-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-12-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-08-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-01-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-10-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-11-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-08-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-07-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-07-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-07-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-05-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2006-08-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-08-12 · Taiwan Food and Drug Administration (TFDA)

North American market evidence 4

• FDA 510(k) clearance K022917 2003-03-04
  HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
• FDA medical device registration 9710580 2001-02-05 – 2014-08-10
  Stimulator, Muscle, Powered; Media, Electroconductive; Electrode, Cutaneous and more (7)
• FDA import refusal 3003514353 2020-06-17 – 2021-05-27
  STIMULATOR, MUSCLE, POWERED
• Health Canada medical device licence 112933

Recent changes 4

• 2026-12-30
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2026-12-30
• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
• 2026-10-14
  Certification expiryMedical device license (Class II) certificate expired on 2026-10-14
• 2025-11-07
  Certification expiryMedical device license (Class I) certificate expired on 2025-11-07

RSS feed · Recent changes at Taiwanese manufacturers →

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