Daavlin

FDA UDI

Class II (US FDA UDI)

by Daavlin Distributing Co., The

Identity

Trade Name: DAAVLIN FDA UDI
Generic Name: Ultraviolet phototherapy unit, professional FDA UDI
Device Name: 3 Series NeoLux Plus PCT 311-40, 3P FDA UDI
Model / Reference: 3 Series Neolux FDA UDI
Description: 3 Series NeoLux Plus PCT 311-40, 3P FDA UDI

Identifiers

Primary DI / UDI-DI: B2809862NL0040PCT3 FDA UDI
510(k) Number: K230382 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ultraviolet phototherapy unit, professional

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Cleared under the same submission

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: Daavlin Distributing Co., The

Sources (1)

FDA UDI 47ef5226-216d-4bc3-99e8-b84d4217de9e 35 fields · synced Jul 20, 2026