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
- Medical device license (Class I) (1,430)Official registry Valid until 2023-11-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2029-11-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2027-01-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2027-01-20 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-08-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2031-03-19 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2016-07-20 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2027-02-24 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2017-04-30 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-01-26 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2017-07-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-01-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2018-04-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2018-05-24 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2018-05-24 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2013-11-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2014-07-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-10-25 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-12-19 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2029-02-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2025-02-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2029-09-27 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2024-01-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2025-11-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2017-10-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2017-10-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2017-11-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2017-12-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2020-07-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-08-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-11-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-01-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-05-02 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-07-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2020-10-16 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-07-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-12-10 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-06-08 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2024-04-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-07-29 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-03-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2029-10-17 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2030-07-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class III) (94)Official registry Valid until 2031-01-25 · Taiwan Food and Drug Administration (TFDA)
Processes & materials 1
- Biotechnology (664) · Company nameSelf-reported
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
RSS feed · Recent changes at Taiwanese manufacturers →
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