gudid Primary ID: BSP-121-35-00

BioSign hCG card (UDI BSP-121-35-00)

Manufactured by PRINCETON BIOMEDITECH CORPORATION

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The BioSign hCG card (Model/Catalog Number: BSP-121-35-00) is a medical device manufactured by PRINCETON BIOMEDITECH CORPORATION. This product is indexed under FDA Product Code / Category Classification DHA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: BSP-121-35-00
Product Code / EMDN: DHA
Device Name: BioSign hCG card; 35 Test kit
Database Sync Date: 2026-08-09 10:00:19

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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Frequently Asked Questions

Who is the primary manufacturer of BioSign hCG card?

The registered manufacturer of record for BioSign hCG card is PRINCETON BIOMEDITECH CORPORATION.

What is the Primary UDI-DI identifier for BioSign hCG card?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BSP-121-35-00.

What classification code is assigned to this device?

This device is registered under product classification code DHA.

Similar Classification Devices (DHA)

Other Devices by PRINCETON BIOMEDITECH CORPORATION

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