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BioStep CL, Size 27, Right, Rate 64, Dark
EUDAMEDFDA UDIClass I (EU MDR)
Ref BSCL-27R-64D
Identity
- Trade Name
- BioStep CL, Size 27, Right, Rate 64, Dark EUDAMEDBIOSTEP CL FDA UDI
- Generic Name
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
- Device Name
- BIOSTEP CL EUDAMEDBioStep CL, Size 27, Right, Rate 64, Dark FDA UDI
- Model / Reference
- BSCL-27R-64D EUDAMEDFDA UDI
- Description
- BioStep CL, Size 27, Right, Rate 64, Dark FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00713980017325 EUDAMEDFDA UDI
- Basic UDI-DI
- 0713980100040017E 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 CL, Size 27, Right, Rate 64, Dark 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 | 0713980100040017E | 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 ec7f4c5c-15c0-4e47-9fb3-f7f040b62377 61 fields · synced Jun 18, 2026
- FDA UDI 32f34c12-d962-472f-8a43-e05985c9b566 33 fields · synced May 30, 2026