Data / Medical devices / Taiwan / Coreleader Biotech Co., Ltd
Coreleader Biotech Co., Ltd: FDA-registered device maker in New Taipei City, Taiwan, 9 510(k) clearances
Coreleader Biotech Co., Ltd is registered with the FDA (registration 3009317711) in New Taipei City, Taiwan. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 31, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009317711
- Address
- 19F, No. 100, Sec. 1, Xintai 5th Rd. Xizhi Dist., New Taipei City, Taiwan, 22102
- Owner or operator
- Coreleader Biotech Co., Ltd (10040141)
- Roles
- Manufacturer
- First device listed
- March 13, 2012
- Registered through
- 2026
- Brand names listed
- Algi-Fiber, Algi-Pad, Algi-Paster, Bios King, Colla-Algi, Colla-Pad, Hemo-Pad, Hydro-Healer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2015 | K151204 | HEMO-Bandage | QSY | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| February 10, 2015 | K141382 | BIOS KING BIOCELLULOSE FILM | FRO | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| June 6, 2013 | K123394 | CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING | FRO | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| September 23, 2011 | K111578 | CORELEADER COLLA-ALGI FIBER MODEL CAW | FRO | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| September 22, 2011 | K111733 | CORELEADER SCAR-DIMMER | MDA | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| September 7, 2011 | K102944 | CORELEADER HEMO-PAD MODEL CPII 02030 | QSY | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| June 22, 2011 | K102942 | CORELEADER ALGIPLASTER MODEL AP 050501 | FRO | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| May 20, 2011 | K102946 | CORELEADER COLLA-PAD MODEL CS 03030 | KGN | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| April 12, 2011 | K102943 | CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 | FRO | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated July 31, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.