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Lokomat®Pro 6.3 PE Motivation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 63060
by Hocoma AG
Identity
- Trade Name
- Lokomat®Pro 6.3 PE Motivation EUDAMEDLokomat FDA UDI
- Generic Name
- Treadmill/elliptical gait rehabilitation system FDA UDI
- Device Name
- LokomatPro EUDAMED
- Model / Reference
- 63060 EUDAMEDPro 6.3 PE Motivation FDA UDI
Identifiers
- Catalog Number
- 63060 FDA UDI
- Primary DI / UDI-DI
- 07640174660483 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017466L6U8 EUDAMED
- FDA Product Code
- BXB FDA UDI
- EMDN Code
- N010299 NEUROLOGIC PHYSIOTHERAPHY DEVICES - OTHER EUDAMED
- GMDN Term
- Treadmill/elliptical gait rehabilitation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5380 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
Lokomat®Pro 6.3 PE Motivation by Hocoma Ag — Class IIa — 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 | 764017466L6U8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hocoma AG
- EUDAMED SRN
- CH-MF-000014672
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3f0b4526-dbfb-4727-ac32-bd3efc1b9647 61 fields · synced Jul 8, 2026
- FDA UDI 9819a30a-522f-4c70-a402-10e4635f9ad1 33 fields · synced May 29, 2026