BEUDAMED
    FDA Registration Active 🇨🇳 China

    Infinity Endo Coronal Shaper Blue Files

    Reg #: 3015136927 · FEI: 3015136927 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN ROGIN MEDICAL CO., LTD
    Registration Number
    3015136927
    FEI Number
    3015136927
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
    City
    shenzhen Guangdong
    Country
    CN

    Owner / Operator

    Firm Name
    SHENZHEN ROGIN MEDICAL CO., LTD
    Operator Number
    10058732
    Address
    Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518129
    Country
    CN
    Correspondent
    Xiaoran Xu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    File, Pulp Canal, Endodontic EKS

    Proprietary Names

    Infinity Endo Coronal Shaper Blue Files Infinity Endo C Files Infinity Endo Ultra Conservative Files Infinity Endo Retreatment Files Infinity Endo Hedstrom Files Paste Carriers, Files holder, C+ Files, U Files, Microscope Files NiTi Hand Use Files, NiTi K Files/H Files/Reamers, Stainless Steel K Files/H Files/Reamers Super Flexi Files); EZ SHAPER, EZ, R-Shaper, Ino-shaper Files, C Pro Files, PF Files, Micro-Prober, Micro-Shaper, Infinity Endo Stainless Steel K files Infinity Endo Gold Files Infinity Endo Coronal Shaper Gold Files NiTi Rotary Files (Entrance File; Vari-Taper File; Retreatment Files; SUP-Taper File; Blue HA Sup-Taper Files; Endo Training Kit, Niti Spreader, Niti Plugger Gold HA Sup-Taper files; Wave File; Recip-one file; Multi-taper files; Sup-Taper Next; Pre-shaper Files; Hero-S Files; Infinity Endo Blue Files

    Establishment Types

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