One Step Fentanyl Test Cassette (Urine) (UDI D-GBFEN-102aHGQK)
Manufactured by Healgen Scientific Limited Liability Company
Device Regulatory Overview
The One Step Fentanyl Test Cassette (Urine) (Model/Catalog Number: GBFEN-102a) is a medical device manufactured by Healgen Scientific Limited Liability Company. This product is indexed under FDA Product Code / Category Classification W0102160508 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GBFEN-102a
- Product Code / EMDN
- W0102160508
- Device Name
- One Step Fentanyl Test Cassette (Urine)
- Database Sync Date
- 2026-08-09 17:11:35
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 One Step Fentanyl Test Cassette (Urine)?
The registered manufacturer of record for One Step Fentanyl Test Cassette (Urine) is Healgen Scientific Limited Liability Company.
What is the Primary UDI-DI identifier for One Step Fentanyl Test Cassette (Urine)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-GBFEN-102aHGQK.
What classification code is assigned to this device?
This device is registered under product classification code W0102160508.
Similar Classification Devices (W0102160508)
Other Devices by Healgen Scientific Limited Liability Company
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