BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Bioretec Ltd.

    Reg #: 3005536892 · FEI: 3005536892 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Bioretec Ltd.
    Registration Number
    3005536892
    FEI Number
    3005536892
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Yrittajankulma 5
    City
    Tampere Pirkanmaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    DEN220030

    Owner / Operator

    Firm Name
    Bioretec Ltd.
    Operator Number
    9093133
    Address
    Yrittajankulma 5
    City
    Tampere
    State
    FI-NOTA
    Postal Code
    FI-33710
    Country
    FI
    Correspondent
    Mari S Ruotsalainen

    US Agent

    Business Name
    RAF Solutions Inc.
    Contact Name
    Edwin Lindsay
    Address
    10124 Nw 53rd St
    City
    Sunrise
    State
    FL
    ZIP
    33351
    Country
    US
    Email
    [email protected]
    Phone
    305 9607262

    Products

    Device Name Product Code
    Gauge, Depth HTJ
    Absorbable Metallic Bone Fixation Fastener QJD
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Orthopedic Manual Surgical Instrument LXH
    Instrument, Manual, Surgical, General Use MDM
    Screw, Fixation, Bone HWC
    Pin, Fixation, Smooth HTY

    Proprietary Names

    Activa RemeOs RemeOs Screw LAG Solid ActivaScrew Interference RemeOs Instrument Activa Instrument RemeOs Instruments Activa Instruments ActivaScrew Cannulated ActivaScrew ActivaPinTM ActivaNailTM Conical

    Establishment Types

    Manufacture Medical Device