FDA Registration Active 🇩🇪 Germany

BAUERFEIND AG

Reg #: 8010507 · FEI: 3005091242 · Expires 2026
Products
14
Proprietary Names
152
Establishment Types
1
Classifications
14

Registration Details

Registration Name
BAUERFEIND AG
Registration Number
8010507
FEI Number
3005091242
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Triebeser Strasse 16
City
ZEULENRODA-TRIEBES Thuringia
Country
DE

Regulatory Submissions

510(k) Number
K860826

Owner / Operator

Firm Name
BAUERFEIND AG
Operator Number
8010507
Address
TRIEBESER STRASSE 16, --
City
ZEULENRODA-TRIEBES
State
DE-NOTA
Postal Code
07937
Country
DE
Correspondent
Ines - Exner

US Agent

Business Name
Bauerfeind US, Inc.
Contact Name
Michael Cannon
Address
75 14th St Ne Ste 2350
City
Atlanta
State
GA
ZIP
30309
Country
US
Phone
703 5877825

Products

Device Name Product Code
Orthosis, Corrective Shoe KNP
Joint, Hip, External Brace ITS
Orthosis, Lumbar IQE
Device, Prosthesis Alignment IQO
Aid, Transfer IKX
Sling, Arm ILI
Orthosis, Sacroiliac, Soft IPW
Orthosis, Limb Brace IQI
Orthosis, Thoracic IPT
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
Orthosis, Cervical IQK
Support, Arm IOY
Joint, Ankle, External Brace ITW
Orthosis, Lumbo-Sacral IPY

Proprietary Names

Orthosis, Corrective Shoe, Post-OP-Forefoot/Heel Relief Shoe, SofTec Coxa CoxaTrain LordoLoc ES SecuTec Dorso LumboLoc Forte XT Sports Back Support LumboLoc Forte ES LumboLoc Forte SP b:joynz back support straight b:joynz back support waisted LumboTrain waisted LumboTrain ES LumboTrain LumboTrain straight DorsoTrain LordoLoc SecuTec Lumbo LumboLoc LumboLoc Forte SofTec Dorso LumboLoc ES LumboTrain Lady Spinova Immo SofTec Lumbo Lumbo Plus ViscoSpot, ViscoHeel, ViscoBalance, ViscoPed, ViscoHeel K ViscoPed S VenoTrain glider plus OmoLoc SacroLoc SacroLoc ES GenuTrain P3 OmoTrain GenuTrain S Pro GenuLoc ErgoPad weightflex 2 ErgoPad work:h ErgoPad ball & racket ErgoPad redux heel 2 SecuTec Genu SecuTec Omo ErgoPad ski & skate ErgoPad redux heel AirLoc, SofTec OA, MyoTrain, ValguLoc, Sportfraeseinlagen ManuLoc long Sports Elbow Support Sports Knee Strap MOS Genu, ManuLoc long Plus MalleoLoc, ManuLoc Rhizo long GenuTrain S, Sports Knee Support SofTec Genu, Sports Insoles Run & Walk GloboTec Isoflex Sports Insoles Ski & Skate Sports Elbow Strap Sports Insoles Ball & Racket ManuLoc Rhizo ErgoPad run & walk GenuPoint ManuLoc Rhizo long Plus MalleoLoc L MalleoLoc L3 SecuTec OA ValguLoc II CaligaLoc GenuTrain OA SofTec OA Plus ErgoPad Sensitive GloboTec Polydor professional Ferse GloboTec Junior GloboTec PP-Flex GloboTec Globotherm-Isoflex TRIactive GloboTec Alpha-Cork GloboTec Plastic GloboTec Elastra-Kork ErgoPad redux hallux GloboTec Starflex GloboTec comfort ErgoPad work ErgoPad system:s GloboTec GloboPlast GloboTec Patricia GloboTec Flexible Cork GloboTec Active GloboTec Soft ErgoPad weightflex b:joynz knee support b:joynz wrist support SecuTec Genu Flex RhizoLoc OA Outdoor Compression Elbow Support ManuRhizoLoc OmoTrain S ManuTrain GenuTrain GenuTrain A3 Outdoor Compression Ankle Support Sports Compression Knee Support Outdoor Knee Support Sports Compression Elbow Support EpiPoint Outdoor Compression Knee Support Outdoor Ankle Support ManuLoc Sports Compression Ankle Support Sports Wrist Strap Sports Achilles Support RhizoLoc Sports Ankle Support Dynamic EpiTrain Spinova Osteo Spinova Osteo ES VenoTrain business CerviLoc S CerviLoc Cervical Orthoses pitcher elbow support Sports Elbow Brace b:joynz elbow support Sports Ankle Support b:joynz ankle support AchilloTrain MalleoTrain Plus MalleoTrain MalleoTrain S open heel MalleoTrain S AchilloTrain Pro Spinova Immo Plus Spinova Unload Plus Spinova Support Plus Classic Spinova Stabi Classic Spinova Immo Plus Classic Spinova Unload Classic Spinova Support Plus VenoTrain VenoTrain curaflow

Establishment Types

Manufacture Medical Device