HUNG CHUN BIO-S CO., LTD.

Unified Business No.

28816624

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 12, Luke 1st Rd., Luzhu Dist., Kaohsiung City 821011, Taiwan (R.O.C.)↗
Kaohsiung City (7,253) · Luzhu Dist. (462)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Cheng Hung-chun

Phone

07-6955369

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · TIEAN ELECTRICAL ENGINEERING CO., LTD.、Tai An Tien Chi Chang Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Certifications 23

• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-06-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-04-22 · 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 2025-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-07-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-07-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-06-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-12-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-02-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-10-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-07-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-11-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-11-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-06-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-07-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2027-03-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-07-27 · Taiwan Food and Drug Administration (TFDA)

Patents 1

• 2021 Positioning device for implant

North American market evidence 4

• FDA 510(k) clearance K172821 2018-06-11
  Ti-one 101 TS Dental Implant System
• FDA 510(k) clearance K151362 2016-05-05
  HC Spinal System
• FDA 510(k) clearance K110425 2012-07-27
  HC-BIOS DENTAL IMPLANT
• FDA medical device registration 3009761487 2012-08-16 – 2018-12-17
  Implant, Endosseous, Root-Form; Accessories, Implant, Dental, Endosseous; Abutment, Implant, Dental, Endosseous

Government programs & awards 2

• SBIR (Small Business Innovation Research) program 2020 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration
• SBIR (Small Business Innovation Research) program 2017 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 2

• 2025-11-27
  Certification expiryMedical device license (Class I) certificate expired on 2025-11-27
• 2025-10-16
  Certification expiryMedical device license (Class I) certificate expired on 2025-10-16

RSS feed · Recent changes at Taiwanese manufacturers →

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