Identity
- Trade Name
- REAL Immersive System FDA UDI
- Generic Name
- Mental health/function therapeutic software, virtual reality FDA UDI
- Device Name
- REAL i-Series FDA UDI
- Model / Reference
- RLE1-A FDA UDI
- Description
- REAL i-Series FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815948024229 FDA UDI
- FDA Product Code
- PWC FDA UDI
- GMDN Term
- Mental health/function therapeutic software, virtual reality FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mental health/function therapeutic software, virtual realityMindfulness/behavioural therapy software, non-clinician-consultative
REAL Immersive System by Penumbra, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA UDI 9348f3dd-1124-4d93-96f3-628dbc1a4a51 33 fields · synced May 30, 2026