BEUDAMED
    EU Manufacturer 🇸🇬 Singapore Active

    Vela Operations Singapore Pte. Ltd.

    SRN: SG-MF-000025684 · 50 Science Park Road, 117406 Singapore, Singapore
    View on EUDAMED
    Basic UDI-DIs
    75
    Total Devices
    82
    On Market
    82
    Off Market
    0
    Certificates
    4
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    50 Science Park Road, 117406 Singapore, Singapore
    Email
    [email protected]
    Phone
    +65 6672 6060
    Website
    www.veladx.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 66
    Eu Ivdr 9
    Classification
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    Eu Ivd General 61
    Eu Ivd Class A 9
    Eu Ivd Annex 2 List B 3
    Eu Ivd Annex 2 List A 2
    Device Types
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    Certificate Health

    Total
    4
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    4
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) HL 20744998-1 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) HL 2074998-1 May 26, 2025
    IVDD Annex IV Section 4 IL 2074998-2 May 26, 2025
    IVDD Annex IV Section 4 IL 2074998-1 May 26, 2025

    Market Presence

    Devices from this manufacturer are available in 1 country across Europe.

    🇩🇪 Germany

    Device Portfolio

    Name
    Great Basin Bordetella Direct Test
    Great Basin Group B Streptococcus Test
    Great Basin Stool Bacterial Pathogens Panel
    RapidKey COVID-19 Antigen Self Test (1)
    RapidKey COVID-19 Antigen Self Test (2)
    RapidKey COVID-19 Antigen Self Test (25)
    RapidKey COVID-19 Antigen Self Test (5)
    RapidKey COVID-19 Antigen Self Test (7)
    Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)
    Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)
    Sentosa SA BKV Controls (8x3)
    Sentosa SA BKV PCR Test (4X48)
    Sentosa SA BKV PCR Test (4x24)
    Sentosa SA BKV Quantitation Controls (4x2)
    Sentosa SA BKV Quantitation Standards (2x13)
    Sentosa SA BRAF V600 PCR Test (4x8)
    Sentosa SA C. diff PCR Test v2.0 (4x24)
    Sentosa SA CHIKV RT-PCR Test (4x8)
    Sentosa SA CMV Controls Set (8x3)
    Sentosa SA CMV Quantitation Controls (4x2)
    Sentosa SA CMV Quantitative PCR Test (4x24)
    Sentosa SA Dengue I-IV RT-PCR Test (4x8)
    Sentosa SA Direct MRSA/SA PCR Test (4x24)
    Sentosa SA EBV Controls Set (8x3)
    Sentosa SA EBV PCR Test (4X48)
    Sentosa SA EBV PCR Test (4x24)
    Sentosa SA EBV Quantitation Controls (4x2)
    Sentosa SA EBV Quantitation Standards (2x13)
    Sentosa SA HHV6 Controls Set (8x3)
    Sentosa SA HHV6 Quantitation Controls (4x2)
    Sentosa SA HHV6 Quantitative PCR Test
    Sentosa SA HSV1/2 Controls Set (8x3)
    Sentosa SA HSV1/2 PCR Test (4x24)
    Sentosa SA HSV1/2 PCR Test (4x24)
    Sentosa SA HSV1/2 PCR Test (4x48)
    Sentosa SA HSV1/2 Quantitation Controls (4x2)
    Sentosa SA HSV1/2 Quantitation Standards (2x13)
    Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test
    Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24)
    Sentosa SA KRAS PCR Test (4x8)
    Sentosa SA NRAS PCR Test (4x8)
    Sentosa SA Norovirus RT-PCR Test v2.0 (4x24)
    Sentosa SA RSV RT-PCR Test
    Sentosa SA Rotavirus RT-PCR Test (4x24)
    Sentosa SA Salmonella PCR Test (4x8)
    Sentosa SA Strep A PCR Test (4x8)
    Sentosa SA VZV Controls (8x3)
    Sentosa SA VZV PCR Test (4x24)
    Sentosa SA VZV PCR Test (4x48)
    Sentosa SA VZV Quantitation Controls (4x2)
    View all 82 devices →