eudamed_udi Primary ID: D-697424646OPI000MV56

Opiate(OPI) Rapid Test Kit(Urine) (UDI D-697424646OPI000MV56)

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 Opiate(OPI) Rapid Test Kit(Urine) (Model/Catalog Number: OPI-1011/OPI-1012/OPI-1014) is a medical device manufactured by SAFECARE BIOTECH (HANGZHOU) CO., LTD.. This product is indexed under FDA Product Code / Category Classification W0102160508 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: OPI-1011/OPI-1012/OPI-1014
Product Code / EMDN: W0102160508
Device Name: Opiate(OPI) Rapid Test Kit(Urine)
Database Sync Date: 2026-08-09 18:44:06

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 Opiate(OPI) Rapid Test Kit(Urine)?

The registered manufacturer of record for Opiate(OPI) Rapid Test Kit(Urine) is SAFECARE BIOTECH (HANGZHOU) CO., LTD..

What is the Primary UDI-DI identifier for Opiate(OPI) Rapid Test Kit(Urine)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-697424646OPI000MV56.

What classification code is assigned to this device?

This device is registered under product classification code W0102160508.

Similar Classification Devices (W0102160508)

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

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