Unified Business No.

13111887

Industry

Fabricated Metal Products (25,390)

Main products

Other fabricated metal products (10,961)

Location

2 F., No. 92, Luke 5th 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

Chang Tu-huo

Phone

07-6956688

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · ANCHOR FASTENERS INDUSTRIAL CO., LTD.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Certifications 25

• Medical device license (Class I) (1,430)Official registry Valid until 2018-08-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-09-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-06-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-06-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-11-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-11-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-09-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-05-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-01-20 · 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 II) (794)Official registry Valid until 2021-07-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-11-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-02-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2022-08-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2022-08-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-02-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-11-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-01-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-03-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-09-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-04-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-04-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-04-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2031-02-25 · Taiwan Food and Drug Administration (TFDA)

Patents 1

• 2022 Dental implant

North American market evidence 3

• FDA 510(k) clearance K152576 2016-06-02
  Anker II Dental Implant System
• FDA 510(k) clearance K142557 2015-09-21
  Anker Dental Implant System - SB-III, ST and AT series
• FDA medical device registration 3009325911 2013-11-26 – 2016-11-20
  Implant, Endosseous, Root-Form; Abutment, Implant, Dental, Endosseous; Handle, Instrument, Dental and more (5)

Similar companies 10

• Dentauspex Corporation · Yunlin County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.
• TAIWAN IMPLANT TECHNOLOGY CO., LTD. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other pharmaceuticals & medical supplies retail n.e.c.
• HUANG LIANG BIOMEDICAL TECHNOLOGY CO., LTD. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.
• T-PLUS IMPLANT TECH. CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.
• M.D.B.T. CO., LTD. · Tainan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.
• CHENG ANN TECHNOLOGY CO., LTD. · Taichung City NT$100–500M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.
• NO.1 BIOTECHNOLOGY CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.
• DERMACARE BIOMED INC. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.
• VASOBYPASS MEDICAL TECHNOLOGY CORPORATION · Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.
• QIN CHUANG PRECISION TECHNOLOGY CO., LTD. · Pingtung County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other medical devices & supplies manufacturing n.e.c.

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