BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    STREIFENEDER ortho.production gmbH

    Reg #: 8010401 · FEI: 5812 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    158
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    STREIFENEDER ortho.production gmbH
    Registration Number
    8010401
    FEI Number
    5812
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MOOSFELDSTRASSE 10
    City
    EMMERING Bavaria
    Country
    DE

    Owner / Operator

    Firm Name
    Streifeneder ortho.production GmbH
    Operator Number
    8010401
    Address
    MOOSFELDSTRASSE 10, --
    City
    EMMERING
    State
    Bavaria
    Postal Code
    82275
    Country
    DE
    Correspondent
    Verena - Seitz

    US Agent

    Business Name
    College Park Industries
    Contact Name
    Julie Carver
    Address
    27955 College Park Dr
    City
    Warren
    State
    MI
    ZIP
    48088
    Country
    US
    Email
    [email protected]
    Phone
    800 7287950

    Products

    Device Name Product Code
    Joint, Knee, External Limb Component ISY
    Joint, Knee, External Brace ITQ
    Device, Prosthesis Alignment IQO
    Orthosis, Limb Brace IQI
    Orthosis, Foot Drop OHI
    Prosthesis, Thigh Socket, External Component ISS
    Insoles, Medical KYS
    Component, External, Limb, Ankle/Foot ISH
    Joint, Ankle, External Brace ITW
    Orthosis, Corrective Shoe KNP
    Band Or Belt, Pelvic Support ISR
    Valve, Prosthesis ISP
    Sling, Arm, Overhead Supported ILE
    Orthosis, Lumbar IQE

    Proprietary Names

    KINEGEN.air Modular 4-Bar Linkage Knee Joint Modular Single Axis Knee Joint Polycentric Knee Joint with hydraulic swing phase control Modular Knee Joint with Lock Rotation Adapter Tube Clamp Adapter Clutch-Lock 301 -Plastic- Clutch-Lock 151 -Aluminum- Clutch-Lock 401 -Aluminum- Brake Knee Joint with Pneumatic Swing Phase Control Polycentric Knee Joint with pneumatic swing Shuttle-Lock 402 -Aluminum- Shuttle-Lock 202 -Aluminum- Brake Knee Joint with lock Easy-Lock 103 Modular Brake Knee Joint Slide.fit - Slip-on aid Modular Knee Joint KINEGEN.air active KINEGEN.stream Modular Light Weight Knee Joint KINEGEN.basic KINEGEN.guard KINEGEN.smart Shuttle-Lock 302 -Plastic- Easy-Lock 153 -Aluminum- Easy-Lock 303 -Plastic- Double Adapter Clutch-Lock 501 -Aluminum- Clutch-Lock 101 -Plastic- Socket Attachment Block Easy-Lock 403 -Aluminum- Socket Adapter Easy-Lock 503 -Aluminum- Slip-on aid for knee prostheses Slide Adapter Shuttle-Lock 502 -Aluminum- Modular Extension Assist Easy-Lock 203 -Aluminum- Connection Adapter Shuttle-Lock 102 -Plastic- Shuttle-Lock 152 -Aluminum- Clutch-Lock 201 -Aluminum- Artikon.junior-Knee Joint Bars, bar width 12 mm, 14 mm or 16 mm Knee Brace, straight, Knee Orthosis for immobilisation GenuSupport.frontal - Hard Frame Knee Orthosis GenuSupport Vario-Test Tube, only trial purpose -Aluminum- Sliding Plate for modular prostheses -Aluminum- Adjusting Device for modular prostheses -Aluminum/Steel- Foot Postural Support Orthosis Dorsal Night Stabilisation Splint GenuMax Knee Joint Support with silicone pads AeroWalker.short, pneumatic transtibial-foot-orthosis PediSupport.dorsal AeroWalker, pneumatic transtibial-foot-orthosis PeroSupport.pro Ankle-Foot-Orthosis, dynamic Peroneal spring, thermoplastic mouldable PeroSupport PeroSupport.tec ComfortSil.soft -6 mm-, without distal connection ContexGel.protect, Protective cover for ContexGel.sleeve ContexGel.basic -3 mm-, without distal connection ClassicSil.soft -6 mm-, without distal connection ComfortSil.basic -3 mm-, with distal connection ClearSil.compression, Post surgical compression liner -Set 1- ContexGel.soft -6 mm-, with distal connection ComfortSil.soft -6 mm-, with distal connection ContexGel.soft+ -9 mm-, with distal connection DuoSil.basic, with distal connection Skin-Care Liner -3 mm- DAW-Slipper, donning aid for AK-prostheses ClassicSil.soft -6 mm-, with distal connection ContexGel.sleeve, Knee Sleeve ContexGel.protect ClearSil.compression, Post surgical compression liner ContexGel.soft+ -9 mm-, with outer matrix, with distal connection ClearSil.basic, without distal connection ContexGel.basic -3 mm-, with outer matrix; without distal connection ContexGel.soft+ -9 mm-, with outer matrix, without distal connection ContexGel.soft -6 mm-, with outer matrix, without distal connection ClassicSil.basic -3 mm-, without distal connection AK-Control.Sil -2 mm-, with distal connection, without silicone strip ContexGel.basic -3 mm-, with distal connection ClassicSil.basic -3 mm-, with distal connection ComfortSil.basic -3 mm-, without distal connection ContexGel.basic -3 mm-, with outer matrix; with distal connection ContexGel.soft+ -9 mm-, without distal connection ClearSil.basic, with distal connection ContexGel.soft -6 mm-, with outer matrix, with distal connection Gel Liner; Silicone Liner; Above Knee & Below Knee Liner; Post surgical compression Liner; Gel Knee Sleeve AK-Control.Sil -2 mm-, with distal connection, with silicone strip ContexGel.soft -6 mm-, without distal connection Nylon Stocking Terrycloth BK-Stump Sock Silicone Insoles, 3/4 length, with duolastic-cover, Silicone Heel Cup, Silicone Heel Wedge, S.A.C.H. Foot for Men up to 150 kg with Adapter Ankle Block -poplar wood- S.A.C.H. Foot for Men for 225 kg with adapter GO.free Carbon Foot S.A.C.H. Foot Adapter -Stainless Steel- S.A.C.H. Foot for Bathing Ankle Block -PUR- light S.A.C.H. Foot Adapter -Stainless Steel- 150 kg GO.smart Carbon Foot Connection Cap for single-axis-foot Single-Axis-Foot Geriatric-Single-Axis-Foot Pirogoff-Foot S.A.C.H. Foot for Men for 175 kg with adapter Dynamic Foot with split toe Dynamic Foot with closed toe S.A.C.H. Foot with Toes for Children Ankle Block -wood- S.A.C.H. Foot Adapter -Titanium- S.A.C.H. Foot with Split Toe GO.free Carbon Module Single-Axis-Foot Adapter S.A.C.H. Foot Adapter -Aluminum- S.A.C.H. Foot GO.smart Carbon Module SACH Foot for Children with Split Toe Geriatric-Foot light GO.adventure Carbon Module GO.relax Carbon Foot Foot Shell for Carbon Foot GO. Connection Cap for Carbon Foot GO. Wedge set for Carbon Foot GO.free Wedge set for Carbon Foot GO.adventure GO.adventure Carbon Foot Spectra Sock(s) for Carbon Foot GO. GO.relax Carbon Module Transtibial Prosthetic Leg Splint, centered joint head AchilloMax, Achilles Tendon Support with silicone pads, including slide-on assistant Venus - Partial Foot Decompression Shoe, short version Jupiter - Forefoot Relief Shoe Merkur A - Partial Foot Decompression Shoe (Post-Surgical Shoe) Uranus - Partial Foot Decompression Shoe (Post-Surgical Shoe) Mars S - Heel Relief Shoe Komet - Especially low Partial Foot Decompression Shoe in outdoor-design Pluto S - Partial Foot Decompression Shoe (Post-Surgical Shoe) Apollo - Partial Foot Decompression Shoe with zero-heel technology Neptun B - Longterm Surgical Shoe with wide outsole and especially high volume Luna - Longterm Surgical Shoe with 3 removable cushioning soles and reinforced outsole Neptun - Longterm Surgical Shoe Merkur - Forefoot Relief Shoe Mars - Heel Relief Shoe Saturn - Forefoot Relief Shoe AK-Suspender - AK-prosthesis support BK-Suspender - holding aid for BK-prostheses Vacuum Valve, Screw Valve, Flat Rubber Valve -Automatic- or -Plastic Pin-, Active.valve TT, waterproof, Active.valve TF Omosupport.easy OmoSupport.air OmoSupport.gilchrist LumboMax.easy - Lumbar Spine Support

    Establishment Types

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