Identity
- Trade Name
- RV-10 ReJoyce EUDAMEDReJoyce FDA UDI
- Generic Name
- Virtual-display rehabilitation system, passive-support, upper-limb FDA UDI
- Device Name
- ReJoyce Passive Workstation EUDAMEDThe ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities. FDA UDI
- Model / Reference
- RV10 EUDAMEDFDA UDI
- Description
- The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17540176010033 EUDAMEDFDA UDI
- Basic UDI-DI
- 17540176010033HE EUDAMED
- Direct Marketing DI
- 17540176010033 EUDAMED
- FDA Product Code
- ION FDA UDI
- EMDN Code
- Z12069080 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Virtual-display rehabilitation system, passive-support, upper-limb FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Market of Registration
- Belgium 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
RV-10 ReJoyce by Rehabtronics — 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 | 17540176010033HE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rehabtronics
- EUDAMED SRN
- CA-MF-000018807
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 5425fea0-f010-4880-a5dc-aa0262b2af8f 61 fields · synced Jun 19, 2026
- FDA UDI 3ae7a632-042a-4315-81f9-12ecf7ecd3b5 33 fields · synced May 30, 2026