eudamed_udi Primary ID: 06971674864097

Creatinine (CREA)Test Kit (Enzymatic) (UDI 06971674864097)

Manufactured by Biobase Biodustry(Shandong) Co.,Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Creatinine (CREA)Test Kit (Enzymatic) (Model/Catalog Number: R1:18mL×4 R2:6mL×4（709）) is a medical device manufactured by Biobase Biodustry(Shandong) Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W01010207 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R1:18mL×4 R2:6mL×4（709）
Product Code / EMDN: W01010207
Device Name: Creatinine (CREA)Test Kit (Enzymatic)
Database Sync Date: 2026-08-09 16:50:16

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 Creatinine (CREA)Test Kit (Enzymatic)?

The registered manufacturer of record for Creatinine (CREA)Test Kit (Enzymatic) is Biobase Biodustry(Shandong) Co.,Ltd..

What is the Primary UDI-DI identifier for Creatinine (CREA)Test Kit (Enzymatic)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06971674864097.

What classification code is assigned to this device?

This device is registered under product classification code W01010207.

Similar Classification Devices (W01010207)

Other Devices by Biobase Biodustry(Shandong) Co.,Ltd.

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