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BONART CO., LTD.

慶暐醫療器材科技股份有限公司

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1991Founded

NT$50MPaid-in capital

2Plants

24Certifications

NT$20–100MRevenue band (est.)

Unified Business No.: 23969353
Industry: Other Manufacturing (2,432)
Main products: Medical devices & supplies (878)
Location: 4 F.-11, No. 3, Wuquan 1st Rd., Xinzhuang Dist., New Taipei City 248022, Taiwan (R.O.C.)
Keelung City (206) · Anle Dist. (56)
Listing: Not publicly issued (84,625)
Registration status: Approved / Active
Organisation type: Company Limited by Shares
Founded: 1991-01-15
Paid-in capital: NT$ 50,000,000
Representative: Liao Fang-yi
Phone: 02-22983980
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$20–100M estimated
Ownership: Individually held
North American market: FDA 510(k) clearance FDA medical device registration
Representative tenure: In office since 2023-02 (3 yrs); last handover 2023-02 (same surname)
Compliance record: Occupational safety penalties: 1 case(s) in 5 years, latest 2026-04-27, fines NT$ 30,000 (Art. 7) — matched by company name

Plants 2

Plant · 1, 2F, No. 80, Wuxun St., Anle Dist., Keelung City In production
Plant · 4F-11, No. 3, Wuquan 1st Rd., Xinzhuang Dist., New Taipei City In production

Certifications 24

Medical device license (Class I) (1,430)Official registry Valid until 2027-11-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-08-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-03-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-08-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-05-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-07-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-06-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-06-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-08-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-02-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-09-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-09-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-11-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-09-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-10-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-12-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2025-06-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-06-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-01-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-01-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2014-01-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-10-13 · Taiwan Food and Drug Administration (TFDA)

North American market evidence 6

FDA 510(k) clearance K162856 2017-07-18
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
FDA 510(k) clearance K152125 2016-08-15
Oral Surgery System and Accessories
FDA 510(k) clearance K000510 2000-05-15
ART-M1, MODEL M1-1-ART-A1
FDA 510(k) clearance K994203 2000-03-06
ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
FDA 510(k) clearance K994299 2000-03-06
ART-P3, MODEL P3-1-ART-A1
FDA medical device registration 9710363 2001-06-22 – 2017-08-10
Scaler, Ultrasonic; Activator, Ultraviolet, For Polymerization; Drill, Bone, Powered and more (6)

Recent changes 3

2026-10-13
Certification expiryMedical device license (Class II) certificate expired on 2026-10-13
2026-04-27
PenaltiesOccupational safety penalties: latest case 2026-04-27; 1 case(s) in 5 years, fines NT$ 30,000
2026-01-27
Certification expiryMedical device license (Class II) certificate expired on 2026-01-27

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