Coreleader Biotech Co., Ltd.
TaiwanFDA applicant, unverified FDA
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Coreleader Biotech Co., Ltd. makes
Coreleader Biotech Co., Ltd. manufactures wound care dressings, including hydrocolloid-based products like the HYDRO-HEALER and ALGI-FIBER WOUND DRESSING, collagen-based dressings such as the CORELEADER COLLA-PAD and CORELEADER COLLA-ALGI FIBER, and biosynthetic films like BIOS KING BIOCELLULOSE FILM. Their portfolio also includes hemostatic and scar management products, such as the HEMO-PAD and SCAR-DIMMER, as well as adhesive dressings like the ALGIPLASTER and HEMO-Bandage.
The company’s products are regulated under FDA’s 510(k) pathway and fall into Class I and Unclassified (U) device categories. These items are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. Coreleader Biotech Co., Ltd. is based in the United States.
Catalogue
Coreleader Colla-Pad Model Cs 03030 Ref K102946
Regimes: 510(k) Registry: 510(k)Coreleader Hemo-Pad Model Cpii 02030 Ref K102944
Regimes: 510(k) Registry: 510(k)Coreleader Scar-Dimmer Ref K111733
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Coreleader Colla-Algi Fiber Model Caw Ref K111578
Regimes: 510(k) Registry: 510(k)HEMO-Bandage Ref K151204
Regimes: 510(k) Registry: 510(k)Bios King Biocellulose Film Ref K141382
Regimes: 510(k) Registry: 510(k)Coreleader Algiplaster Model Ap 050501 Ref K102942
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Coreleader Biotech Co., Ltd New Taipei City · TW FEI 3009317711
Frequently asked questions
How many devices does Coreleader Biotech Co., Ltd. have in the registry?
The registry currently lists 9 devices for Coreleader Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coreleader Biotech Co., Ltd.'s devices?
Among its 9 most recently registered devices, Coreleader Biotech Co., Ltd. has devices listed in FDA 510(k) (9 devices).
What risk classes do Coreleader Biotech Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Coreleader Biotech Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Coreleader Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Coreleader Biotech Co., Ltd. include CORELEADER COLLA-PAD MODEL CS 03030, CORELEADER HEMO-PAD MODEL CPII 02030, CORELEADER SCAR-DIMMER and CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING.
Which FDA establishments are linked to Coreleader Biotech Co., Ltd.?
1 FDA establishment is linked to Coreleader Biotech Co., Ltd. in the registry; they are listed on the company page.