eudamed_udi
Primary ID: 08500176515794
DERMLITE (UDI 08500176515794)
Manufactured by DermLite LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DERMLITE - Primary ID 08500176515794
Device Regulatory Overview
The DERMLITE (Model/Catalog Number: DLCKi13P) is a medical device manufactured by DermLite LLC. This product is indexed under FDA Product Code / Category Classification Z12040108 within international Unique Device Identification (UDI) compliance databases.
ACTIVE SAFETY RECALL ALERT
1 Event(s) Found
Enforcement actions are currently active for this product line.
ID: Z-1506-2023
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DERMLITE DL4W, REF: DL4W, Rx Only MD, CE...
🔒 Compromised Lot & Serial Numbers Locked
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Technical Specifications
- Model Number
- DLCKi13P
- Product Code / EMDN
- Z12040108
- Device Name
- DL Connection Kit for iPhone 13 Pro
- Database Sync Date
- 2026-08-09 16:48:52
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of DERMLITE?
The registered manufacturer of record for DERMLITE is DermLite LLC.
What is the Primary UDI-DI identifier for DERMLITE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08500176515794.
What classification code is assigned to this device?
This device is registered under product classification code Z12040108.
Similar Classification Devices (Z12040108)
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