TWDBTaiwan Manufacturer Database 中文

CORELEADER BIOTECH CO., LTD.

康力得生技股份有限公司

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1Plants
49Certifications
1Patents
< NT$20MRevenue band (est.)
Unified Business No.
28922569
Industry
Other Manufacturing (2,436)
Main products
Medical devices & supplies (878)
Location
19 F., No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221411, Taiwan (R.O.C.)
New Taipei City (16,829) · Xizhi Dist. (1,300)
Listing
Not publicly issued (84,625)
Organisation type
Company Limited by Shares
Representative
Tsao Tien-min
Phone
02-26968880
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
Representative tenure
In office since at least 2013 (13+ years)

Certifications 49

Processes & materials 1

Patents 1

  • 2023 Inflatable frame and tent having same

North American market evidence 10

  • FDA 510(k) clearance K151204 2015-07-31
    HEMO-Bandage
  • FDA 510(k) clearance K141382 2015-02-10
    BIOS KING BIOCELLULOSE FILM
  • FDA 510(k) clearance K123394 2013-06-06
    CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
  • FDA 510(k) clearance K111578 2011-09-23
    CORELEADER COLLA-ALGI FIBER MODEL CAW
  • FDA 510(k) clearance K111733 2011-09-22
    CORELEADER SCAR-DIMMER
  • FDA 510(k) clearance K102944 2011-09-07
    CORELEADER HEMO-PAD MODEL CPII 02030
  • FDA 510(k) clearance K102942 2011-06-22
    CORELEADER ALGIPLASTER MODEL AP 050501
  • FDA 510(k) clearance K102946 2011-05-20
    CORELEADER COLLA-PAD MODEL CS 03030
  • FDA 510(k) clearance K102943 2011-04-12
    CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
  • FDA medical device registration 3009317711 2012-03-13 – 2016-12-20
    Dressing, Wound, Drug; Hemostatic Wound Dressing Without Thrombin Or Other Biologics; Wound Dressing With Animal-Derived Material(S) and more (4)

Government programs & awards 1

  • SBIR (Small Business Innovation Research) program 2016 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 4

  • Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-20
  • Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-11
  • Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
  • Certification expiryMedical device license (Class I) certificate expired on 2025-11-13

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