Bioptimal I N T Pte L T D

FDA Filings

This page includes the latest FDA filings for Bioptimal I N T Pte L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8043983
• FEI Number: 3002806593
• Name: Bioptimal International Pte. Ltd.
• Owner & Operator: JW ICU Medical Limited
• Contact Address: 68 Dalian Road ; Wei Hai CN-37 Shandong 264209 CN
• Official Correspondent:
  • Chun Guang - Yu
  • 86-631-5655290-x
• US Agent:
  • Dennis Bassett
  • BIOMEDICAL SALES INTERNATIONAL, INC.
  • 513 2586555
  • 513 7728388
  • dwbassett@cs.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 36 Jalan Tukang ; SINGAPORE South West, 619266 SG
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08886483501492 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000201-15	2023-11-13
GUDID 08886483508859 BIOPTIMAL INTERNATIONAL PTE. LTD.	Central Venous Catheter Kit 24-000251-03	2023-11-08
GUDID 08886483507524 BIOPTIMAL INTERNATIONAL PTE. LTD.	Embolectomy Catheter EC-0001-003	2023-11-08
GUDID 08886483506008 BIOPTIMAL INTERNATIONAL PTE. LTD.	Central Venous Catheter Kit 25-000017-01	2023-11-08
GUDID 08886483505636 BIOPTIMAL INTERNATIONAL PTE. LTD.	Central Venous Catheter Kit 25-000009-03	2023-11-08
GUDID 08886483502949 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-55	2023-11-08
GUDID 08886483501829 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000074-10	2023-11-08
GUDID 08886483501560 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000202-02	2023-11-08
GUDID 08886483501393 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000151-12	2023-11-08
GUDID 08886483504257 BIOPTIMAL INTERNATIONAL PTE. LTD.	ACCUTRANS Disposable Pressure Monitoring Kit 22-000948-21	2021-05-14
GUDID 08886483508330 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables BL-0003-021	2021-03-31
GUDID 08886483508323 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000813-30	2021-03-31
GUDID 08886483507531 BIOPTIMAL INTERNATIONAL PTE. LTD.	Biosensors Embolectomy Catheter EC-0001-004	2020-10-09
GUDID 08886483507517 BIOPTIMAL INTERNATIONAL PTE. LTD.	Biosensors Embolectomy Catheter EC-0001-002	2020-10-09
GUDID 08886483507500 BIOPTIMAL INTERNATIONAL PTE. LTD.	Biosensors Embolectomy Catheter EC-0001-001	2020-10-09
GUDID 08886483507432 BIOPTIMAL INTERNATIONAL PTE. LTD.	Inline Sensor Assembly and Inline Temperature Sensor CA-0001-001	2020-10-09
GUDID 08886483506961 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables BL-0003-013	2020-10-09
GUDID 08886483506954 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables BL-0003-008	2020-10-09
GUDID 08886483506947 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables BL-0003-007	2020-10-09
GUDID 08886483504394 BIOPTIMAL INTERNATIONAL PTE. LTD.	Biosensors Embolectomy Catheter 23-000004-07	2020-10-09
GUDID 08886483504387 BIOPTIMAL INTERNATIONAL PTE. LTD.	Biosensors Embolectomy Catheter 23-000004-06	2020-10-09
GUDID 08886483504370 BIOPTIMAL INTERNATIONAL PTE. LTD.	Biosensors Embolectomy Catheter 23-000004-05	2020-10-09
GUDID 08886483504356 BIOPTIMAL INTERNATIONAL PTE. LTD.	Biosensors Embolectomy Catheter 23-000004-03	2020-10-09
GUDID 08886483504349 BIOPTIMAL INTERNATIONAL PTE. LTD.	Biosensors Embolectomy Catheter 23-000004-02	2020-10-09
GUDID 08886483503816 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000941-17	2020-10-09
GUDID 08886483503809 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000941-15	2020-10-09
GUDID 08886483503403 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000910-90	2020-10-09
GUDID 08886483503397 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000910-82	2020-10-09
GUDID 08886483503380 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000910-77	2020-10-09
GUDID 08886483503373 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000910-65	2020-10-09
GUDID 08886483503366 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000910-63	2020-10-09
GUDID 08886483503359 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000910-62	2020-10-09
GUDID 08886483503342 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000910-59	2020-10-09
GUDID 08886483503144 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-92	2020-10-09
GUDID 08886483503137 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-91	2020-10-09
GUDID 08886483503120 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-90	2020-10-09
GUDID 08886483503113 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-89	2020-10-09
GUDID 08886483503106 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-88	2020-10-09
GUDID 08886483503090 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-87	2020-10-09
GUDID 08886483503083 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-86	2020-10-09
GUDID 08886483503076 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-85	2020-10-09
GUDID 08886483503069 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-84	2020-10-09
GUDID 08886483503052 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-82	2020-10-09
GUDID 08886483503045 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-81	2020-10-09
GUDID 08886483503038 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-80	2020-10-09
GUDID 08886483503021 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-73	2020-10-09
GUDID 08886483503014 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-72	2020-10-09
GUDID 08886483503007 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-71	2020-10-09
GUDID 08886483502994 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-70	2020-10-09
GUDID 08886483502987 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-63	2020-10-09
GUDID 08886483502970 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-62	2020-10-09
GUDID 08886483502963 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-58	2020-10-09
GUDID 08886483502956 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-57	2020-10-09
GUDID 08886483502932 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-52	2020-10-09
GUDID 08886483502925 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-49	2020-10-09
GUDID 08886483502918 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-46	2020-10-09
GUDID 08886483502901 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-39	2020-10-09
GUDID 08886483502895 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-37	2020-10-09
GUDID 08886483502888 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-35	2020-10-09
GUDID 08886483502871 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-28	2020-10-09
GUDID 08886483502864 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-27	2020-10-09
GUDID 08886483502857 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-19	2020-10-09
GUDID 08886483502840 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-18	2020-10-09
GUDID 08886483502833 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-14	2020-10-09
GUDID 08886483502826 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000895-06	2020-10-09
GUDID 08886483502703 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000893-09	2020-10-09
GUDID 08886483502697 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000893-04	2020-10-09
GUDID 08886483502680 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000893-03	2020-10-09
GUDID 08886483502482 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000841-10	2020-10-09
GUDID 08886483502475 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000841-09	2020-10-09
GUDID 08886483502468 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000841-08	2020-10-09
GUDID 08886483502451 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000841-07	2020-10-09
GUDID 08886483501959 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000149-00	2020-10-09
GUDID 08886483501904 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000116-04	2020-10-09
GUDID 08886483501805 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000074-01	2020-10-09
GUDID 08886483501768 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000071-09	2020-10-09
GUDID 08886483501751 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000071-08	2020-10-09
GUDID 08886483501720 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000049-08	2020-10-09
GUDID 08886483501621 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000005-09	2020-10-09
GUDID 08886483501607 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000005-01	2020-10-09
GUDID 08886483501461 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000201-12	2020-10-09
GUDID 08886483501447 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000201-04	2020-10-09
GUDID 08886483501355 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000148-02	2020-10-09
GUDID 08886483501348 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000138-01	2020-10-09
GUDID 08886483501317 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000130-01	2020-10-09
GUDID 08886483501300 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000119-01	2020-10-09
GUDID 08886483501294 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000117-11	2020-10-09
GUDID 08886483501287 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000117-10	2020-10-09
GUDID 08886483501270 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000117-09	2020-10-09
GUDID 08886483501263 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000117-08	2020-10-09
GUDID 08886483501256 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000117-07	2020-10-09
GUDID 08886483501249 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000116-09	2020-10-09
GUDID 08886483501232 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000116-08	2020-10-09
GUDID 08886483500761 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000050-92	2020-10-09
GUDID 08886483500686 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000050-70	2020-10-09
GUDID 08886483500525 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000048-77	2020-10-09
GUDID 08886483500099 BIOPTIMAL INTERNATIONAL PTE. LTD.	Thermodilution Catheter and Accessories 21-000009-41	2020-10-09
GUDID 98888893309173 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000841-10	2020-07-01
GUDID 98888893001169 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000941-04	2020-06-30
GUDID 98888893001046 BIOPTIMAL INTERNATIONAL PTE. LTD.	BIOTRANS™ Pressure Monitoring Kits 22-000910-90	2020-06-30
PMN K101669 | DQO Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Thermodilution Catheter and	2010-07-26
PMN K083384 | DQO Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	and Accessories	2010-01-07
PMN K083384 | DQO Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Thermodilution Catheter	2010-01-07
PMN K983372 | DRS Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Bioport System	2007-11-29
PMN K981747 | DRS Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Biotrans? Pressure Monitoring Kits	2007-11-29
PMN K981745 | DRS Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Biotrans? Reusable Sensor Base	2007-11-29
PMN K973477 | DXE Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Biosensors Embolectomy Catheter	2007-11-29
PMN K912172 | KRB Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Safetywedge? Relief	2007-11-29
PMN K911710 | DQO Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Heparin Coated Thermodilution	2007-11-29
PMN K911710 | DQO Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Catheter and Accessories	2007-11-29
PMN K070710 | DRS Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Pressure Monitoring System	2007-11-29
PMN K070710 | DRS Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Accutrans? Disposable	2007-11-29
PMN K022004 | DQO Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Inline Sensor Assembly and	2007-11-29
PMN K002786 | FOZ Bioptimal International Pte. Ltd. [JW ICU Medical Limited]	Biosensors Central Venous Catheter	2007-11-29

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091932375	Singapore,Singapore -> Los Angeles, California	MEDICAL DEVICE INVOICE NO PI-A941	43 PKG
2020091825588	Singapore,Singapore -> Los Angeles, California	MEDICAL DEVICE INVOICE NO PI-A941	43 PKG
2020081428114	Singapore,Singapore -> Los Angeles, California	MEDICAL DEVICE INVOICE NO PI-A833	48 PKG
202008012990	Singapore,Singapore -> Los Angeles, California	MEDICAL DEVICE INVOICE NO PI-A703	70 PKG
202007256566	Singapore,Singapore -> Los Angeles, California	MEDICAL DEVICE INVOICE NO PI-A703	70 PKG
2020071519247	Singapore,Singapore -> Los Angeles, California	MEDICAL DEVICE INVOICE NO PI-A703	70 PKG
2020070340290	Singapore,Singapore -> Los Angeles, California	MEDICAL DEVICE INVOICE NO PI-A703	70 PKG
2020070251460	Singapore,Singapore -> Los Angeles, California	MEDICAL DEVICE INVOICE NO PI-A703	70 PKG