BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    AGAPLASTIC IND. COM. LTDA.

    Reg #: 9615834 · FEI: 3003080016 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    9
    Establishment Types
    4
    Classifications
    7

    Registration Details

    Registration Name
    AGAPLASTIC IND. COM. LTDA.
    Registration Number
    9615834
    FEI Number
    3003080016
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    RUA CUBA NO 353
    City
    RIO DE JANEIRO
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K101348

    Owner / Operator

    Firm Name
    AGAPLASTIC IND. COM. LTDA.
    Operator Number
    9040469
    Address
    RUA CUBA NO 353, Penha
    City
    RIO DE JANEIRO-RJ
    State
    BR-RJ
    Postal Code
    21020-160
    Country
    BR
    Correspondent
    TEREZA CRISTINA - DE OLIVEIRA REIS

    US Agent

    Business Name
    MDI CONSULTANTS, INC.
    Contact Name
    Alan Schwartz
    Address
    55 NORTHERN BLVD.
    City
    GREAT NECK
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Depressor, Tongue, Non-Surgical FMA
    Percussor GWZ
    Nasal Spray, Ent Delivery KCO
    Holding Chambers, Direct Patient Interface NVP
    Dispenser, Liquid Medication KYX
    Irrigator, Sinus KAR
    Syringe, Ent KCP

    Proprietary Names

    TIC-TONG FLAVORED TONGUE DEPRESSOR TIC-TONG FLAVORED TONGUE DEPRESSOR BIO Dalmatian Reflex Hammer AGACHAMBER SPACER AGACHAMBER SPACER EXTRA PEDIATRIC ROCKET DOSER NOSE WASH MAX Nose Wash Syringe DISPOSITIVO PARA LAVAGEM NASAL PEQUENOS CUIDADOS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Foreign Private Label Distributor Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device