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Digital Therapist
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Digital TherapistModel Version 2
Identity
- Trade Name
- Digital Therapist EUDAMEDFDA UDI
- Generic Name
- Virtual-display rehabilitation system, non-supportive, home-use FDA UDI
- Device Name
- Digital Therapist EUDAMED
- Model / Reference
- Version 2 EUDAMEDDigital Therapist EUDAMED2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05065013876009 EUDAMEDFDA UDI
- Basic UDI-DI
- 5065013876DTC4 EUDAMED
- FDA Product Code
- ISD FDA UDI
- EMDN Code
- Z12069082 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Virtual-display rehabilitation system, non-supportive, home-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5360 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Portugal 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
Digital Therapist by Sword Health, S.a. — 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 | 5065013876DTC4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sword Health S.A.
- EUDAMED SRN
- PT-MF-000039126
Sources (2)
- EUDAMED 72b3f083-1343-452d-8a4d-ee8229586480 61 fields · synced Jul 13, 2026
- FDA UDI 8a7c5d60-fcec-4202-af92-84e7871f6b79 32 fields · synced May 29, 2026