gudid Primary ID: R1:48mL2 R2:12mL2

BIOBASE (UDI R1:48mL2 R2:12mL2)

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 BIOBASE (Model/Catalog Number: R1:48mL2 R2:12mL2) is a medical device manufactured by Biobase Biodustry(Shandong)Co., Ltd.. This product is indexed under FDA Product Code / Category Classification GTQ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R1:48mL2 R2:12mL2
Product Code / EMDN: GTQ
Device Name
Database Sync Date: 2026-08-09 09:06:42

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 BIOBASE?

The registered manufacturer of record for BIOBASE is Biobase Biodustry(Shandong)Co., Ltd..

What is the Primary UDI-DI identifier for BIOBASE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is R1:48mL2 R2:12mL2.

What classification code is assigned to this device?

This device is registered under product classification code GTQ.

Similar Classification Devices (GTQ)

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

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