Identity
- Trade Name
- Rheo Knee® EUDAMEDRheo Knee FDA UDI
- Generic Name
- Mechatronic external knee prosthesis FDA UDI
- Device Name
- RHEO KNEE 3 WP Loaner FDA UDI
- Model / Reference
- RKN13140 EUDAMEDFDA UDIBU00053 EUDAMED
- Description
- RHEO KNEE 3 WP Loaner FDA UDI
Identifiers
- Catalog Number
- RKN13140 FDA UDI
- Primary DI / UDI-DI
- 05690967610517 EUDAMEDFDA UDI
- Basic UDI-DI
- 5690967BU00053NE EUDAMED
- FDA Product Code
- ISY FDA UDI
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) EUDAMED
- GMDN Term
- Mechatronic external knee prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 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
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
Category: Mechatronic external knee prosthesis
Rheo Knee by Ossur Americas — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ossur Americas
Sources (2)
- FDA UDI 826ed779-f498-4699-b0cb-f78aa0e25fb0 35 fields · synced Jun 18, 2026
- EUDAMED 9daca70d-6726-4518-a726-a7ebb347cb38 61 fields · synced Jun 18, 2026