← Back to catalogue
NxSTEP UNWEIGHING SYSTEM w/o HARNESS
EUDAMEDFDA UDIClass I (EU MDR)
Ref 950-484
Identity
- Trade Name
- NxSTEP UNWEIGHING SYSTEM w/o HARNESS EUDAMEDNxSTEP FDA UDI
- Generic Name
- Mobile gait rehabilitation system, harness-support FDA UDI
- Device Name
- Offset Unweighing System EUDAMEDNxSTEP Unweighing System, without Harness FDA UDI
- Model / Reference
- 950-484 EUDAMEDFDA UDI
- Description
- NxSTEP Unweighing System, without Harness FDA UDI
Identifiers
- Catalog Number
- 950-484 FDA UDI
- Primary DI / UDI-DI
- 00718175004845 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 w/o HARNESS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biodex Medical Systems
- EUDAMED SRN
- US-MF-000028834
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED dc3c3117-906e-4879-8cda-53b3a1c6bf5b 61 fields · synced Jul 9, 2026
- FDA UDI 536e96b3-028e-41d5-b3f0-3e4fc6597a59 34 fields · synced May 30, 2026