Identity
- Trade Name
- NxSTEP UNWEIGHING SYSTEM EUDAMEDNxSTEP FDA UDI
- Generic Name
- Mobile gait rehabilitation system, harness-support FDA UDI
- Device Name
- Offset Unweighing System EUDAMEDNxSTEP Unweighing System, 115VAC FDA UDI
- Model / Reference
- 950-485 EUDAMEDFDA UDI
- Description
- NxSTEP Unweighing System, 115VAC FDA UDI
Identifiers
- Catalog Number
- 950-485 FDA UDI
- Primary DI / UDI-DI
- 00718175004852 EUDAMEDFDA UDI
- Basic UDI-DI
- 071817521657 EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y050201 STANDING SUPPORT GAIT TRAINERS EUDAMED
- GMDN Term
- Mobile gait rehabilitation system, harness-support FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3825 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NxSTEP UNWEIGHING SYSTEM by Biodex Medical Systems — 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 | 071817521657 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biodex Medical Systems
- EUDAMED SRN
- US-MF-000028834
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ccca1d05-a9bd-4425-a120-9879324286de 61 fields · synced Jul 18, 2026
- FDA UDI b0abb7e0-b24a-42aa-8fe3-dff7241a1564 34 fields · synced May 30, 2026