← Back to catalogue

Apk

FDA UDI

Class II (US FDA UDI)

by Apk Technology

Identity

Trade Name
APK FDA UDI
Generic Name
Ultraviolet phototherapy unit, professional FDA UDI
Device Name
Ultraviolet Phototherapy Device FDA UDI
Model / Reference
AUC004 FDA UDI
Description
Ultraviolet Phototherapy Device FDA UDI

Identifiers

Primary DI / UDI-DI
06946725599990 FDA UDI
510(k) Number
K250425 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultraviolet phototherapy unit, professional

Apk by Apk Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultraviolet phototherapy unit, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Apk Technology

Sources (1)

  • FDA UDI c26894b5-1325-44af-ad96-de26e5ee55a3 34 fields · synced May 30, 2026