Identity
- Trade Name
- INFRABALDAN FDA UDI
- Generic Name
- Red/infrared light phototherapy unit FDA UDI
- Model / Reference
- INFRABALDAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053782383313 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Red/infrared light phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Red/infrared light phototherapy unit
Infrabaldan by B&M Srl Marketing Nel Benessere — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- B&M Srl Marketing Nel Benessere
Sources (1)
- FDA UDI eae6bd84-cdff-4364-99c3-3b023ba0f661 32 fields · synced Jun 6, 2026