Identity
- Trade Name
- Controller Unit (CU+) FDA UDI
- Generic Name
- Red-light phototherapy unit, professional FDA UDI
- Model / Reference
- CU+ FDA UDI
Identifiers
- Primary DI / UDI-DI
- B271CUP0 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Red-light phototherapy unit, professional 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
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
Category: Red-light phototherapy unit, professional
Controller Unit (CU+) by Medi-Tech International Corporation — 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
- Medi-Tech International Corporation
Sources (1)
- FDA UDI 1f4f8335-3b12-4a6c-a99c-6b44e4c9b7d7 32 fields · synced Jun 1, 2026