HomeSingaporeVela Operations Singapore Pte Ltd

Vela Operations Singapore Pte Ltd

Singapore · Singapore Central Singapore
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Singapore, Australia, Israel — 4 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 3Class II 4Class III 0unclassified 1
plus 9 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
16device registrations
CLASS B 2CLASS C 14
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
13active ARTG entries
IVD Class 1 2IVD Class 2 3IVD Class 3 8
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 States9 registration records, 1 510(k), 0 PMA, 3 excluded
Manufacturer names merged into this page: Vela Operations Singapore Pte Ltd

Company information

Country
Singapore
City
Singapore Central Singapore

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12023 · K232092

FDA listed device types

Real Time Nucleic Acid Amplification System 1High Throughput Dna Sequence Analyzer 1Hiv-1 Genotyping Assay Using Ngs Technology 1Herpes Simplex Virus Nucleic Acid Amplification Assay 1Clinical Sample Concentrator 1Station, Pipetting And Diluting, For Clinical Use 1Reagents For Molecular Diagnostic Test Systems 1Reagents, 2019-Novel Coronavirus Nucleic Acid 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232092Great Basin Toxigenic C. difficile Direct Test (CDF2)2023-11-14

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