metene BLOOD GLUCOSE MONITORING SYSTEM

FDA UDI

Class II (US FDA UDI)

by Metene Limited

Identity

Trade Name: metene BLOOD GLUCOSE MONITORING SYSTEM FDA UDI
Generic Name: Glucose analyser IVD, home-use FDA UDI
Device Name: Lancet 150 Pcs Strip 150 Pcs Control solution 1 Bottle Lancing device 1 Pcs FDA UDI
Model / Reference: TD-4116 FDA UDI
Description: Lancet 150 Pcs Strip 150 Pcs Control solution 1 Bottle Lancing device 1 Pcs FDA UDI

Identifiers

Primary DI / UDI-DI: 00850048540798 FDA UDI
510(k) Number: K151100 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose analyser IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose analyser IVD, home-use

metene BLOOD GLUCOSE MONITORING SYSTEM by Metene Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Metene Limited

Sources (1)

FDA UDI cf461576-08ac-41e9-9ab2-a1cf47b7e6ad 34 fields · synced May 30, 2026