HealthyMe Early Detection Pregnancy Test (UDI L031-20198-101)
Manufactured by Acon Laboratories, Inc.
Device Regulatory Overview
The HealthyMe Early Detection Pregnancy Test (Model/Catalog Number: L031-20198-101) is a medical device manufactured by Acon Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification LCX within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- L031-20198-101
- Product Code / EMDN
- LCX
- Device Name
- Early Detection Pregnancy Test
- Database Sync Date
- 2026-08-09 09:17:18
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 HealthyMe Early Detection Pregnancy Test?
The registered manufacturer of record for HealthyMe Early Detection Pregnancy Test is Acon Laboratories, Inc..
What is the Primary UDI-DI identifier for HealthyMe Early Detection Pregnancy Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is L031-20198-101.
What classification code is assigned to this device?
This device is registered under product classification code LCX.
Similar Classification Devices (LCX)
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