GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ)

FDA UDIEUDAMED

Class II (US FDA UDI)

by Hmd Biomedical, LLC

Identity

Trade Name: GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ) FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Device Name: GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ) FDA UDI
Model / Reference: 3S-01-14010A FDA UDI
Description: GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ) FDA UDI

Identifiers

Catalog Number: 3S-01-14010A FDA UDI
Primary DI / UDI-DI: 04711200721720 FDA UDI
510(k) Number: K182428 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose IVD, kit, electrometry 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose IVD, kit, electrometry Glucose monitoring system IVD, point-of-care

GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ) by Hmd Biomedical, LLC — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED

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Also classified as Glucose monitoring system IVD, point-of-care.

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Fresh Test — Fresh Test, LLC · Class II

Cleared under the same submission

K182428 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Hmd Biomedical, LLC

Sources (2)

FDA UDI 9d8702ce-34c1-4b52-afaa-bd4d3cad9863 36 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 2, 2026