Unified Business No.

12810618

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

2 F., No. 100, 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

Fang Yi-ching

Phone

07-6955533

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 Health Canada medical device licence

Representative tenure

In office since 2022-12 (3 yrs); last handover 2022-12 (same surname)

Compliance record

Labour Standards Act penalties: 1 case(s) in 5 years, latest 2022-07-07, fines NT$ 40,000 (Art. 32) — matched by company name

Certifications 10

• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-07-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-04-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-11-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2013-08-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-09-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-18 · Taiwan Food and Drug Administration (TFDA)

Patents 1

• 2020 Packaging box for dental handpiece

North American market evidence 7

• FDA 510(k) clearance K231864 2024-03-11
  Fiber Optic Brushless Electronic Micromotor, model: iM100
• FDA 510(k) clearance K152146 2015-12-08
  High Speed Handpieces and Accessories
• FDA 510(k) clearance K150798 2015-04-24
  Codent Low Speed Dental Handpieces and Accessories
• FDA 510(k) clearance K133069 2014-10-24
  CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
• FDA 510(k) clearance K033213 2004-02-06
  CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS
• FDA medical device registration 3004082152 2021-11-29 – 2024-03-29
  Handpiece, Air-Powered, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Controller, Foot, Handpiece And Cord
• Health Canada medical device licence 139350

Similar companies 10

• HSI ERH SHENG ENTERPRISE CO., LTD. · Taichung City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale
• ELINE MEDICAL CO., LTD. · Yilan County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale
• CHING MING MEDICAL DEVICE CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale
• NON-CHANGE ENTERPRISE CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical consumables wholesale
• TRONJEN MEDICAL TECHNOLOGY INC. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale
• SLS MEDICAL TECHNOLOGY CORP. LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale
• LAGIS ENTERPRISE CO., LTD. · Taichung City Listed (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• YI LIEN MEDICAL CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• SOCKO MEDICAL CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• JI SHENG MEDICAL COMPANY LIMITED · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.

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