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
- [email protected]
- Phone
- 703 5877825
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2002-02-05 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2013-01-16 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2013-01-16 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2007-12-11 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2025-11-25 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2013-09-16 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2013-01-16 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2001-10-24 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2007-12-11 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2022-06-24 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2007-12-11 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2013-11-04 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2007-12-11 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2013-04-12 |
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