ASTEK TECHNOLOGY LTD.

Unified Business No.

27378647

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Measuring, navigation & control equipment; clocks (485)

Location

1 F., No. 118, Taizi Rd., Taizi Vil., Rende Dist., Tainan City 717001, Taiwan (R.O.C.)↗
Tainan City (8,491) · Rende Dist. (1,143)

Listing

Not publicly issued (84,625)

Organisation type

Limited Company

Representative

Lin Chin-shu

Phone

06-2729488

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 2016 (10+ years)

Certifications 21

• ISO 9001 (4,293)Official registry Valid until 2028-07-25 · Li'enwei International Certification Co., Ltd.
• Medical device license (Class I) (1,430)Official registry Valid until 2025-07-21 · 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 2022-04-16 · 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 2021-10-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-07-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-01-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-03-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-03-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-03-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-10-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2014-09-03 · Taiwan Food and Drug Administration (TFDA)

Patents 4

• 2023 Excrement detection device
• 2023 Intelligent weighing scale system
• 2022 Drug propulsion device for treating internal cavity wound

North American market evidence 2

• FDA 510(k) clearance K183074 2020-01-11
  TENS and EMS Stimulator, TENS Stimulator
• FDA medical device registration 3013077196 2019-10-07 – 2020-02-11
  Stimulator, Nerve, Transcutaneous, For Pain Relief; Stimulator, Muscle, Powered; Massager, Therapeutic, Electric

Recent changes 2

• 2027-01-17
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-17
• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31

RSS feed · Recent changes at Taiwanese manufacturers →

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