GUDIDData
eudamed_udi Primary ID: 06974703168081

mLabs® ImmunoMeter (UDI 06974703168081)

Manufactured by Micropoint Biotechnologies Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for mLabs® ImmunoMeter - Primary ID 06974703168081

Device Regulatory Overview

The mLabs® ImmunoMeter (Model/Catalog Number: m-101) is a medical device manufactured by Micropoint Biotechnologies Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W02010299 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
m-101
Product Code / EMDN
W02010299
Device Name
Fluorescent immunoassay analyser IVD, point-of-care
Database Sync Date
2026-08-09 16:29:24

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 mLabs® ImmunoMeter?

The registered manufacturer of record for mLabs® ImmunoMeter is Micropoint Biotechnologies Co., Ltd..

What is the Primary UDI-DI identifier for mLabs® ImmunoMeter?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974703168081.

What classification code is assigned to this device?

This device is registered under product classification code W02010299.

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