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Lokomat®Pro L6.2 PE 120V
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30005
by Hocoma AG
Identity
- Trade Name
- Lokomat®Pro L6.2 PE 120V EUDAMEDLokomat FDA UDI
- Generic Name
- Treadmill/elliptical gait rehabilitation system FDA UDI
- Device Name
- Lokomat®Pro L6.2 PE 120V EUDAMED
- Model / Reference
- 30005 EUDAMEDPro FDA UDI
Identifiers
- Catalog Number
- 30005 FDA UDI
- Primary DI / UDI-DI
- 07640174660117 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640174660117 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
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 L6.2 PE 120V by Hocoma Ag — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640174660117 | 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 0d1044ae-5e07-4890-8298-f672d4e85f6b 61 fields · synced Jun 18, 2026
- FDA UDI 10f00b7f-e53c-4171-812e-a5980f381a3a 34 fields · synced May 29, 2026