Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009317711

FEI Number

3009317711

Entity Name

CORELEADER BIOTECH CO., LTD

City/State/Country

New Taipei City, TW

Establishment Address

19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 22102, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Coreleader Biotech Co., Ltd (Owner Number: 10040141)

Owner / Operator Contact Address

19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei, TW-NWT 22102, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123394

PMA Number

N/A

All Registered Proprietary Names

Scar-D Colla-Algi Algi-Paster Hydro-Healer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2012-03-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-03-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-03-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-08-07

Official Correspondent

Teeming Tsao

US Agent Details

Feng C Zhou Email: Theneuron@mac.com Phone: (317) 6528154

Related Public Records

Same Entity

Coreleader Biotech Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

Registration Number	Establishment Name	Location
2950792	BIODERMIS LLC	Henderson, NV, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3009192857	Neodyne Biosciences, Inc.	Fremont, CA, US
3005857283	PRECO, LLC	Somerset, WI, US
3019769561	ScarPro NV	Aalter Flanders, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009317711. Last updated year: 2026. Please use registration number 3009317711 when referencing this establishment in official correspondence.