gudid Primary ID: BL 43

NovaLine (UDI BL 43)

Manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The NovaLine (Model/Catalog Number: BL 43) is a medical device manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification FJK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: BL 43
Product Code / EMDN: FJK
Device Name
Database Sync Date: 2026-08-09 09:05:26

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 NovaLine?

The registered manufacturer of record for NovaLine is Bain Medical Equipment (Guangzhou) Co., Ltd..

What is the Primary UDI-DI identifier for NovaLine?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BL 43.

What classification code is assigned to this device?

This device is registered under product classification code FJK.

Similar Classification Devices (FJK)

Other Devices by Bain Medical Equipment (Guangzhou) Co., Ltd.

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