Maglumi 2000 Immunoassay Analyzer

FDA UDI

Class I (US FDA UDI)

by Shenzhen New Industries Biomedical Engineering Co., Ltd.

Identity

Trade Name: Maglumi 2000 Immunoassay Analyzer FDA UDI
Generic Name: Chemiluminescent immunoassay analyser IVD FDA UDI
Model / Reference: 23020006 FDA UDI

Identifiers

Catalog Number: 23020006 FDA UDI
Primary DI / UDI-DI: 06947145582746 FDA UDI
510(k) Number: K162698 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Chemiluminescent immunoassay analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Chemiluminescent immunoassay analyser IVD

Maglumi 2000 Immunoassay Analyzer by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K162698 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.

Sources (1)

FDA UDI eed08375-70eb-4df1-af89-c79a1cbb873c 34 fields · synced May 30, 2026