Identity
- Trade Name
- GAIT TRAINER III, 230V EUDAMEDGait Trainer 3 FDA UDI
- Generic Name
- Standard treadmill, powered FDA UDI
- Device Name
- GAIT TRAINER EUDAMEDGait Trainer 3, 230 VAC FDA UDI
- Model / Reference
- 950-401 EUDAMEDFDA UDI
- Description
- Gait Trainer 3, 230 VAC FDA UDI
Identifiers
- Catalog Number
- 950-401 FDA UDI
- Primary DI / UDI-DI
- 00718175005415 EUDAMEDFDA UDI
- Basic UDI-DI
- 071817521759 EUDAMED
- FDA Product Code
- IOL FDA UDI
- EMDN Code
- Z129006 TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES EUDAMED
- GMDN Term
- Standard treadmill, powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5380 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
Gait Trainer Iii, 230v 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 | 071817521759 | 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 9a8398a4-7349-4ac8-aa5c-8d06d753362d 61 fields · synced Jun 18, 2026
- FDA UDI 7d3268af-80c0-45b2-adff-6eee02920740 34 fields · synced May 30, 2026