510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Coreleader Biotech Co., Ltd

New Taipei City, TW

CORELEADER BIOTECH CO., LTD appears in FDA device records in New Taipei City, TW. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Coreleader Biotech Co., Ltd between 2011 and 2015. The busiest year on record is 2011, with 6. The most recent is 2015, with 2.

Clearances by year, as a table
510(k) clearance decisions for Coreleader Biotech Co., Ltd, by decision year
YearClearances
20116
20131
20152
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K151204HEMO-BandageQSYSubstantially Equivalent
K141382BIOS KING BIOCELLULOSE FILMFROSubstantially Equivalent
K123394CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSINGFROSubstantially Equivalent
K111578CORELEADER COLLA-ALGI FIBER MODEL CAWFROSubstantially Equivalent
K111733CORELEADER SCAR-DIMMERMDASubstantially Equivalent
K102944CORELEADER HEMO-PAD MODEL CPII 02030QSYSubstantially Equivalent
K102942CORELEADER ALGIPLASTER MODEL AP 050501FROSubstantially Equivalent
K102946CORELEADER COLLA-PAD MODEL CS 03030KGNSubstantially Equivalent
K102943CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050FROSubstantially Equivalent

Registered establishments

FDA registered establishments for Coreleader Biotech Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30093177113009317711CORELEADER BIOTECH CO., LTD19F, No. 100, Sec. 1, Xintai 5th Rd., New Taipei City 22102 TW2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain