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Sign in to claim this brandStreifeneder ortho.production GmbH
US
Last updated September 17, 2026
What Streifeneder ortho.production GmbH makes
Streifeneder ortho.production GmbH manufactures prosthetic and orthotic components for lower-limb mobility, including custom socket liners for external limb prostheses, ankle-foot orthoses, and mechanical-resistance knee and ankle prostheses. Their portfolio also includes suspensory and alignment components for non-powered lower-limb prostheses, as well as specialized padding and gel sleeves for improved fit and comfort.
The company’s devices are classified under Class I in the FDA’s regulatory framework and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Streifeneder ortho.production GmbH manufacture?
Streifeneder ortho.production GmbH specializes in prosthetic and orthotic components designed to improve lower-limb mobility. Their devices include external limb prosthesis socket liners, ankle-foot orthoses (AFOs), mechanical-resistance knee and ankle prostheses, as well as suspensory and alignment components for non-powered lower-limb prostheses. They also produce specialized padding and gel sleeves to enhance comfort and fit for users.
Where is Streifeneder ortho.production GmbH based?
The company is based in the United States, where it develops and manufactures its prosthetic and orthotic devices. Their operations align with U.S. medical device regulations, ensuring compliance with applicable standards for these products.
Which regulatory registries list Streifeneder ortho.production GmbH’s devices?
Streifeneder ortho.production GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products under the U.S. regulatory framework, ensuring transparency and traceability for authorized devices.
How are Streifeneder ortho.production GmbH’s devices classified under FDA regulations?
All of Streifeneder ortho.production GmbH’s listed devices fall under Class I classification in the FDA’s regulatory framework. Class I devices are generally considered to pose the lowest risk and typically require only general controls to ensure safety and effectiveness, though specific compliance pathways may still apply depending on the product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 317931954
Catalogue (64)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AK-Control.Sil -2 mm- | 60L50/40 | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R4/L3 | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L50/S | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/45 | FDA UDI | Class I | Active |
| Slide.fit | 17A1/XL | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R6/R1 | FDA UDI | Class I | Active |
| ComfortSil.soft -6mm- | 41L10/25 | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R4/R4 | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/50 | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R6/L2 | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L10/XL | FDA UDI | Class I | Active |
| Padding Set for PeroSupport.tec | 197R10 | FDA UDI | Class I | Active |
| SACH Foot for Children | 30A26/14R | FDA UDI | Class I | Active |
| ContexGel.protect | 3S50/M | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L10/L | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L10/S | FDA UDI | Class I | Active |
| Modular Single Axis Knee Joint | 3A17 | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L50/L | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R6/L4 | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R4/R2 | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/36 | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/32 | FDA UDI | Class I | Active |
| SACH Foot for Children | 30A26/14L | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/55 | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R6/R3 | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R4/R1 | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/42 | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L10/XXL | FDA UDI | Class I | Active |
| SACH Foot for Children | 30A26/18L | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R6/R2 | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R4/L2 | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/25 | FDA UDI | Class I | Active |
| Slide.fit | 17A1/XXL | FDA UDI | Class I | Active |
| Transtibial Exhaust Valve active.valve | 6P50 | FDA UDI | Class I | Active |
| Slide.fit | 17A1/M | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R4/L4 | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L50/M | FDA UDI | Class I | Active |
| SACH Foot for Children | 30A26/20R | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R4/L0 | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/34 | FDA UDI | Class I | Active |
| SACH Foot for Children | 30A26/18R | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/26,5 | FDA UDI | Class I | Active |
| Socket Attachment Block block Ø 148 mm | 12A5 | FDA UDI | Class I | Active |
| SACH Foot for Children | 30A26/16L | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R6/R4 | FDA UDI | Class I | Active |
| AK-Control.Sil -2 mm- | 60L50/38 | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L50/XXL | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R6/L1 | FDA UDI | Class I | Active |
| ContexGel.sleeve | 30L50/XL | FDA UDI | Class I | Active |
| PeroSupport.tec | 197R6/L3 | FDA UDI | Class I | Active |
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