eudamed_udi Primary ID: D-697424646MDOAS000825M

Follicle-Stimulating Hormone (FSH) Rapid Test (Urine) (UDI D-697424646MDOAS000825M)

Manufactured by SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Follicle-Stimulating Hormone (FSH) Rapid Test (Urine) (Model/Catalog Number: FSH-1011/FSH-1012/FSH-1013) is a medical device manufactured by SAFECARE BIOTECH (HANGZHOU) CO., LTD.. This product is indexed under FDA Product Code / Category Classification W0102160301 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: FSH-1011/FSH-1012/FSH-1013
Product Code / EMDN: W0102160301
Device Name: Follicle-Stimulating Hormone (FSH) Rapid Test (Urine)
Database Sync Date: 2026-08-09 17:10:15

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 Follicle-Stimulating Hormone (FSH) Rapid Test (Urine)?

The registered manufacturer of record for Follicle-Stimulating Hormone (FSH) Rapid Test (Urine) is SAFECARE BIOTECH (HANGZHOU) CO., LTD..

What is the Primary UDI-DI identifier for Follicle-Stimulating Hormone (FSH) Rapid Test (Urine)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-697424646MDOAS000825M.

What classification code is assigned to this device?

This device is registered under product classification code W0102160301.

Similar Classification Devices (W0102160301)

Other Devices by SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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