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BioStep XT, Size 27, Left, Rate 31
EUDAMEDFDA UDIClass I (EU MDR)
Ref BSXT-27L-31
Identity
- Trade Name
- BioStep XT, Size 27, Left, Rate 31 EUDAMEDBIOSTEP XT FDA UDI
- Generic Name
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
- Device Name
- BIOSTEP XT EUDAMEDBioStep XT, Size 27, Left, Rate 31 FDA UDI
- Model / Reference
- BSXT-27L-31 EUDAMEDFDA UDI
- Description
- BioStep XT, Size 27, Left, Rate 31 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980028550 EUDAMEDFDA UDI
- Basic UDI-DI
- 0713980100040047L EUDAMED
- FDA Product Code
- ISH FDA UDI
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BioStep XT, Size 27, Left, Rate 31 by Alps South, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0713980100040047L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alps South, LLC
- EUDAMED SRN
- US-MF-000001260
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 1e976587-c1af-4cc6-9cc0-e7ac53a17095 61 fields · synced Jun 18, 2026
- FDA UDI 2019e5b2-457f-40f6-8a0d-beb2fe5e6d57 33 fields · synced May 30, 2026