Identity
- Trade Name
- Reality DTx® EUDAMEDReality DTx FDA UDI
- Generic Name
- Neuromuscular rehabilitation software FDA UDI
- Device Name
- Reality DTx AR Glasses EUDAMEDA software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge. FDA UDI
- Model / Reference
- Reality DTx® EUDAMEDCX-ML2-0001 EUDAMEDML2 v6 FDA UDI
- Description
- A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge. FDA UDI
Identifiers
- Catalog Number
- CX-ML2-0001 FDA UDI
- Primary DI / UDI-DI
- 05065012458114 EUDAMEDFDA UDI
- Basic UDI-DI
- 5065012458CXV1VF EUDAMED
- Direct Marketing DI
- 05065012458114 EUDAMED
- FDA Product Code
- QKC FDA UDI
- EMDN Code
- Z12069092 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Neuromuscular rehabilitation software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5360 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Reality DTx® by Strolll Limited — 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 | 5065012458CXV1VF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Strolll Limited
- EUDAMED SRN
- GB-MF-000027434
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (2)
- EUDAMED 88fbed29-cb15-45f3-b4e2-f37c74d4c457 61 fields · synced Oct 6, 2026
- FDA UDI 7f6fac46-6d1d-4223-8ba7-7c1d1a4cdfbc 35 fields · synced May 30, 2026