BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
京達醫材科技股份有限公司
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1Plants
14Certifications
2Patents
< NT$20MRevenue band (est.)
- Unified Business No.
- 28608626
- Industry
- Other Manufacturing (2,432)
- Main products
- Medical devices & supplies (878)
- Location
- 1F., NO. 59, LUKE 2ND 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
- Su Kuo-tsai
- Phone
- 07-9525999
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- < NT$20M estimated
- Ownership
- Foreign-owned · Switzerland · Le Chi Technology Co., Ltd.、Cheng Kuan Hsing Technology Co., Ltd.、BiomateSwissGmbH (Switzerland)
- North American market
- FDA 510(k) clearance
- Representative tenure
- In office since at least 2014 (12+ years)
Certifications 14
- Medical device license (Class I) (1,430)Official registry Valid until 2022-04-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2027-04-18 · 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 2031-08-25 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2027-07-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2027-08-25 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-04-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2024-09-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2031-03-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2029-05-29 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2023-11-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2027-04-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2027-04-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2026-12-07 · Taiwan Food and Drug Administration (TFDA)
Processes & materials 1
- Medical devices (32) · Company nameSelf-reported
Patents 2
- 2026 Method for laser surface treatment of aggregate and nanostructure thereof
- 2025 Nanostructure of laser surface-treated aggregate
North American market evidence 3
- FDA 510(k) clearance K170732 2018-10-26
Biomate Dental Implant System - FDA 510(k) clearance K142174 2015-03-20
BIOMATE DENTAL IMPLANT SYSTEM - FDA 510(k) clearance K103061 2011-06-20
BIOMATE STERILE ACUPUNCTURE NEEDLE
Recent changes 2
- Certification expiry · UpcomingMedical device license (Class III) certificate expires on 2026-12-07
- Certification expiryMedical device license (Class I) certificate expired on 2026-04-18
RSS feed · Recent changes at Taiwanese manufacturers →
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