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Coreleader Biotech Co., Ltd.

Taiwan · New Taipei City

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 0Class III 0unclassified 3

plus 9 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 9 510(k), 0 PMA

Manufacturer names merged into this page: CORELEADER BIOTECH CO., LTD

FDA 510(k) clearances by year

62011 · K111578

12013 · K123394

22015 · K151204

FDA listed device types

Dressing, Wound, Drug 1Wound Dressing With Animal-Derived Material(S) 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1Elastomer, Silicone, For Scar Management 1

Market	Identifier	Name	Class / date
US	K151204	HEMO-Bandage	2015-07-31
US	K141382	BIOS KING BIOCELLULOSE FILM	2015-02-10
US	K123394	CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING	2013-06-06

Coreleader Biotech Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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