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VELA OPERATIONS SINGAPORE PTE. LTD.

Singapore·SG-MF-000025684

Last updated September 17, 2026

Information

Country
Singapore
Address
50 Science Park Road, Singapore, Singapore
LinkedIn
—
Facebook
—
Phone
+65 6672 6060
PRRC Contact
Boon King Teh
EUDAMED SRN
SG-MF-000025684
FDA FEI Number
3009875001
DUNS Number
595361724

Catalogue (103)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) 300395
FDA UDI
Class IActive
Sentosa SX IA Reagents Kit (8) 300734
FDA UDI
Class IActive
ViroKey™ SX Virus Total Nucleic Acid Kit 300677
FDA UDI
Class IActive
Sentosa SQ Sequencing Solutions (8) 300316
FDA UDI
Class IActive
Sentosa SA201 Real-Time PCR Instrument 400125
FDA UDI
Class IIActive
Sentosa SX IA Reactions Kit (4) 300733
FDA UDI
Class IActive
ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) 301068
FDA UDI
N/AActive
Sentosa ST Template Solutions (8) 300325
FDA UDI
Class IActive
Sentosa ST Template Reagents (8) 300319
FDA UDI
Class IActive
Sentosa SQ HIV-1 Positive Control Kit (96) 300729
FDA UDI
Class IIActive
ViroKey® HT Virus Total Nucleic Acid Kit (4x96) 301088
FDA UDI
N/AActive
Sentosa ST Template Supplies (8) 300328
FDA UDI
Class IActive
Sentosa SQ HIV-1 Positive Control Kit (8) 300800
FDA UDI
Class IIActive
Sentosa SQ 318 Chip Kit (8) 300300
FDA UDI
Class IActive
ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) 301085
FDA UDI
N/AActive
Sentosa SQ Sequencing Supplies (8) 300306
FDA UDI
Class IActive
Sentosa SX IA Solution Kit (8) 300735
FDA UDI
Class IActive
Sentosa ST Template Beads (8) 300322
FDA UDI
Class IActive
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) 300353
FDA UDI
Class IActive
Sentosa SQ HIV-1 Genotyping Reagents (4x24) 300731
FDA UDI
Class IIActive
Sentosa SQ Virus Testing Solutions (4x24) 300732
FDA UDI
Class IIActive
Sentosa SA201 HSV-1/2 PCR Test 300216
FDA UDI
Class IIActive
Sentosa SQ Sequencing Reagents (8) 300313
FDA UDI
Class IActive
Sentosa ST Template Kit (8) 690006
EUDAMED
Class AActive
Sentosa SA Norovirus RT-PCR Test v2.0 (4x24) 300202
EUDAMED
IVD GeneralActive
Sentosa SA EBV PCR Test (4x24) 300106
EUDAMED
IVD GeneralActive
Sentosa SQ CRC Panel (4x8) 690012
EUDAMED
IVD GeneralActive
Sentosa SX Lysis Beads 300291
EUDAMED
Class AActive
Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test 111267
EUDAMED
IVD GeneralActive
Sentosa SA Strep A PCR Test (4x8) 300032
EUDAMED
IVD GeneralActive
ViroKey SX Virus Total Nucleic Acid (4x48) 300678
EUDAMED
Class AActive
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) 300042
EUDAMED
Class AActive
Sentosa SQ 318 Chip Kit (8) 300302
EUDAMED
Class AActive
Sentosa SA BKV Controls (8x3) 300633
EUDAMED
IVD GeneralActive
Sentosa SA VZV Quantitation Standards (2x13) 300078
EUDAMED
IVD GeneralActive
Sentosa SA HSV1/2 PCR Test (4x48) 300671
EUDAMED
IVD GeneralActive
RapidKey COVID-19 Antigen Self Test (1) 301111
EUDAMED
IVD GeneralActive
Sentosa SA NRAS PCR Test (4x8) 300086
EUDAMED
IVD GeneralActive
Great Basin Stool Bacterial Pathogens Panel 300780
EUDAMED
IVD GeneralActive
Sentosa SA EBV Controls Set (8x3) 300631
EUDAMED
IVD GeneralActive
Sentosa SA vanA/vanB PCR Test 300015, 300016
EUDAMED
IVD GeneralActive
Sentosa SX101 400089
EUDAMEDFDA UDI
Class AActive
Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24) 300145
EUDAMED
IVD GeneralActive
Sentosa SA VZV Quantitation Controls (4x2) 300077
EUDAMED
IVD GeneralActive
ViroKey Flu A/B & RSV RT-PCR Extension Kit 301074
EUDAMED
IVD GeneralActive
Sentosa SX Whole Blood Kit (4x24) 300252
EUDAMED
Class AActive
Sentosa SA C. diff PCR Test v2.0 (4x24) 3000249
EUDAMED
IVD GeneralActive
RapidKey COVID-19 Antigen Self Test (25) 301115
EUDAMED
IVD GeneralActive
ViroKey SARS-CoV-2 RT-PCR Test v2.0 (4x96) 301086
EUDAMED
IVD GeneralActive
RapidKey COVID-19 Antigen Self Test (7) 301114
EUDAMED
IVD GeneralActive

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