ACARE TECHNOLOGY CO., LTD.

Unified Business No.

28398868

Industry

Other Manufacturing (2,436)

Main products

Medical devices & supplies (878)

Location

5F.-4, NO. 24, WUQUAN 2ND RD., XINZHUANG DIST., NEW TAIPEI CITY 24892, TAIWAN (R.O.C.)↗
New Taipei City (16,829) · Xinzhuang Dist. (2,990)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2006-09-11

Paid-in capital

NT$ 99,000,000

Representative

Cheng Lin-ta

Phone

02-22988170

Website

https://www.acaretech.com/zh/index.html

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · Chien Ta Instruments Co., Ltd.

North American market

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

Representative tenure

In office since at least 2015 (11+ years)

Plants 2

• Plant · 4F-4, No. 24, Wuquan 2nd Rd., Xinzhuang Dist., New Taipei City↗ In production
• Plant 2 · 6F-3, No. 24, Wuquan 2nd Rd., Xinzhuang Dist., New Taipei City↗ In production

Certifications 27

• Medical device license (Class I) (1,430)Official registry Valid until 2025-06-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-09-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-09-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-07-21 · 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 2023-12-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-08-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-08-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-10-25 · 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 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-07-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-05-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-12-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-05-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-12-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-03-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-01-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-01-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-01-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2022-02-14 · Taiwan Food and Drug Administration (TFDA)
• ISO 13485 (310)Self-reported

Processes & materials 1

• Testing & inspection (1,056) · Assembly & inspectionSelf-reported

Patents 3

• 2026 Smart ring
• 2023 Respiration detection fabric
• 2021 Blower device

North American market evidence 4

• FCC equipment authorization 2ATBR 2019-05-09
• FDA 510(k) clearance K182950 2019-08-23
  Acare Suction Unit
• FDA medical device registration 3006395447 2007-01-12 – 2023-11-07
  Oximeter; Regulator, Pressure, Gas Cylinder; Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge and more (11)
• Health Canada medical device licence 143267

Recent changes 2

• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
• 2026-07-21
  Certification expiryMedical device license (Class I) certificate expired on 2026-07-21

RSS feed · Recent changes at Taiwanese manufacturers →

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