BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    SANCTUARY HEALTH SDN BHD

    Reg #: 3005497907 · FEI: 3005497907 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    SANCTUARY HEALTH SDN BHD
    Registration Number
    3005497907
    FEI Number
    3005497907
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 16 Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan
    City
    Chemor Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K212037

    Owner / Operator

    Firm Name
    Sanctuary Health Sdn Bhd
    Operator Number
    9080281
    Address
    No. 16 Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan
    City
    Chemor
    State
    Perak
    Postal Code
    31200
    Country
    MY

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Frame, Rubber Dam EJE
    Clamp, Rubber Dam EEF
    Barrier, Std, Oral Sex MSC
    Retractor, All Types EIG
    Forceps, Rubber Dam Clamp EJG
    Exerciser, Non-Measuring ION
    Handle, Instrument, Dental EJB
    Components, Exercise IOD
    Dental Prophylaxis Kit NYC
    Dam, Rubber EIE

    Proprietary Names

    Sanctuary ComfiTract Latex- Free Cheek Retractor Dental Dam Premium Kit

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)