Identity
- Trade Name
- MindPod Dolphin EUDAMEDFDA UDI
- Generic Name
- Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
- Device Name
- MindPod Dolphin EUDAMEDMindPod Dolphin is immersive serious gaming software for adult patients and healthy participants. MindPod Dolphin motivates patients and participants to make high-intensity and high-dose non-task oriented upper-body exploratory movements in a challenging and beautiful environment. This targets motor and cognitive rehabilitation and provides a form of exercise. The experience can be provided under either continuous or intermittent supervision by a caregiver. FDA UDI
- Model / Reference
- DLP-01 EUDAMEDFDA UDI
- Description
- MindPod Dolphin is immersive serious gaming software for adult patients and healthy participants. MindPod Dolphin motivates patients and participants to make high-intensity and high-dose non-task oriented upper-body exploratory movements in a challenging and beautiful environment. This targets motor and cognitive rehabilitation and provides a form of exercise. The experience can be provided under either continuous or intermittent supervision by a caregiver. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760272650026 EUDAMEDFDA UDI
- Basic UDI-DI
- 376027265DLP0177 EUDAMED
- FDA Product Code
- ION FDA UDI
- EMDN Code
- Z12069092 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Virtual-display rehabilitation system, non-supportive, clinical
MindPod Dolphin by MindMaze SA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- MindMaze SA
Sources (2)
- FDA UDI a736e37b-ac3a-4a80-b4a2-6aa567e4c0fa 34 fields · synced Jul 26, 2026
- EUDAMED 2294f57c-3964-48f9-8dd9-7560edc16b06 61 fields · synced Jul 26, 2026