FDA.report

Bioptimal International Pte. Ltd.

Matched from indexed company URL: BIOPTIMAL INTERNATIONAL PTE. LTD.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80439833016261803Bioptimal International Pte. Ltd.1N2026-01-0114 Kaki Bukit View SINGAPORE South East SG 415950

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
452211741677834K983372BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BPDRS1999-02-05
452211127346914K981747BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXXDRS1998-08-20
452211541975350K981745BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXXDRS1998-07-17
452211441001417K973477BIOSENSORS EMBOLECTOMY CATHETERDXE1998-09-04
452211095123954K912172SAFEWEDGE(TM) RELIEF VALVE DEVICEKRB1991-09-27
452211355190454K911710HEPARIN COATED THERMODILUTION CATH & ACCESSORIESDQO1991-10-23
452211846579606K242863Bioptimal Bipolar Pacing CatheterLDF2025-06-15
452211748942436K182463Silicone Foley CatheterEZL2019-11-06
452211751433405K101669THERMODILUTION CATHETERDQO2010-07-01
452211596926331K083384THERMODILUTION CATHETERDQO2010-01-05
452212003364914K070710ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEMDRS2007-04-19
452211167180885K022004CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1DQO2003-03-12
452211104421727K002786BIOSENSORS CENTRAL VENOUS CATHETER KITSFOZ2000-11-17

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQO42010-07-01
DRS42007-04-19
LDF12025-06-15
EZL12019-11-06
FOZ12000-11-17
DXE11998-09-04
KRB11991-09-27

PMA

PMN

Applications

GUDID