Identity
- Trade Name
- UVBioTek FDA UDI
- Generic Name
- Ultraviolet phototherapy unit, professional FDA UDI
- Device Name
- Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 24 lamps, each 72" in height. Clinic use only. FDA UDI
- Model / Reference
- 2400B FDA UDI
- Description
- Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 24 lamps, each 72" in height. Clinic use only. FDA UDI
Identifiers
- Catalog Number
- 2400B FDA UDI
- Primary DI / UDI-DI
- B343B2400 FDA UDI
- 510(k) Number
- K933954 FDA UDI
- FDA Product Code
- FTC FDA UDI
- GMDN Term
- Ultraviolet phototherapy unit, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4630 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 5740 Square inch FDA UDIWeight — 500 Pound FDA UDI
Category: Ultraviolet phototherapy unit, professional
UVBioTek by Medtek Lighting Corp — 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
- Medtek Lighting Corp
Sources (1)
- FDA UDI fd5546c4-428e-4c18-b519-420fc792581f 36 fields · synced Jun 1, 2026