BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Clear Aligner(EAB II)

    Reg #: 3027285899 · FEI: 3027285899 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ANGELALIGN TECHNOLOGY PTE. LTD.
    Registration Number
    3027285899
    FEI Number
    3027285899
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 RAFFLES QUAY #14-06
    City
    singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K203688

    Owner / Operator

    Firm Name
    ANGELALIGN TECHNOLOGY PTE. LTD.
    Operator Number
    10087640
    Address
    6 RAFFLES QUAY #14-06
    City
    singapore
    State
    Central Singapore
    Postal Code
    048580
    Country
    SG
    Correspondent
    Hilary Zhang

    US Agent

    Business Name
    Prime Path Medtech, Inc.
    Contact Name
    Bill Jacqmein
    Address
    811 Lakeview Drive Shoreview
    City
    Arden Hills
    State
    MN
    ZIP
    55126
    Country
    US
    Email
    [email protected]
    Phone
    404 2166190

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    Clear Aligner(EAB II)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device