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

Taipei, TW

BIOTEQUE CORP. appears in FDA device records in Taipei, TW. FDA records list 14 510(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
14
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 14 510(k) clearances for Bioteque Corp. between 1992 and 2025. The busiest year on record is 2000, with 2. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bioteque Corp., by decision year
YearClearances
19921
19991
20002
20011
20021
20042
20051
20111
20161
20201
20221
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGESubstantially Equivalent
K210419BIOTEQ Drainage Catheter BT-PDS-seriesFGESubstantially Equivalent
K200103BIOTEQ Drainage Catheter Set (One Step Type)FGESubstantially Equivalent
K150932Sheath IntroducerDRESubstantially Equivalent
K102633BIOTEQ ANGIOGRAPHIC CATHETERDQOSubstantially Equivalent
K033862BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCKFGESubstantially Equivalent
K033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SETFADSubstantially Equivalent
K032292BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEXFOZSubstantially Equivalent
K013634BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACKFJKUnknown
K012526BIOTEQUE SCALP VEIN SETFPASubstantially Equivalent
K002449BIOTEQ I.V. (INTRAVENOUS) SETFPASubstantially Equivalent
K992930BIOTEQUE HEMODIALYSIS BLOOD TUBING SETFJKSubstantially Equivalent
K993118BIOTEQUE A.V. FISTULA NEEDLE SETFIESubstantially Equivalent
K915491CURELLEHHKSubstantially Equivalent

Registered establishments

FDA registered establishments for Bioteque Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30124805353012480535BIOTEQUE CORP.5F-6, No.23, Sec.1, Chang-An E. Rd., Taipei 104 TW2026and 2 more, listed in full below

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