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Bioptimal International Pte. , Ltd.

Singapore · Singapore South East

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 0Class II 8Class III 0

plus 14 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

12device registrations

CLASS B 6CLASS D 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class III 2IIa 3

HKHong KongMDACS

3valid listings

Class II 2Class IV 1

ILIsraelAMAR

4registrations

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 States14 registration records, 2 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: Bioptimal International Pte. Ltd. · BIOPTIMAL INTERNATIONAL PTE. LTD.

FDA 510(k) clearances by year

12025 · K242863

12026 · K252702

FDA listed device types

Probe, Thermodilution 1Electrode, Pacemaker, Temporary 1Catheter, Flow Directed 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Catheter, Intravascular, Diagnostic 1Transducer, Blood-Pressure, Extravascular 1Catheter, Retention Type, Balloon 1Catheter, Embolectomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252702	Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N	2026-05-28
US	K242863	Bioptimal Bipolar Pacing Catheter	2025-06-15
BR	80102511140	CATETER PARA EMBOLECTOMIA	Class II

Bioptimal International Pte. , 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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