GUDIDData
eudamed_udi Primary ID: D-697424646GON001KFYS

Gonorrhoea Rapid Test(Swab) (UDI D-697424646GON001KFYS)

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

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Gonorrhoea Rapid Test(Swab) - Primary ID D-697424646GON001KFYS

Device Regulatory Overview

The Gonorrhoea Rapid Test(Swab) (Model/Catalog Number: GON-6012) is a medical device manufactured by SAFECARE BIOTECH (HANGZHOU) CO., LTD.. This product is indexed under FDA Product Code / Category Classification W0105090199 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
GON-6012
Product Code / EMDN
W0105090199
Device Name
Gonorrhoea Rapid Test(Swab)
Database Sync Date
2026-08-09 17:01:18

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Gonorrhoea Rapid Test(Swab)?

The registered manufacturer of record for Gonorrhoea Rapid Test(Swab) is SAFECARE BIOTECH (HANGZHOU) CO., LTD..

What is the Primary UDI-DI identifier for Gonorrhoea Rapid Test(Swab)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-697424646GON001KFYS.

What classification code is assigned to this device?

This device is registered under product classification code W0105090199.

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