GlucoLeader Enhance Blood Glucose vial packed test strip

FDA UDIEUDAMED

Class II (US FDA UDI)

by Hmd Biomedical, LLC

Identity

Trade Name: GlucoLeader Enhance Blood Glucose vial packed test strip FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: GlucoLeader Enhance GL Blood Glucose vial packed test strip FDA UDI
Model / Reference: 3S-01-14003Y FDA UDI
Description: GlucoLeader Enhance GL Blood Glucose vial packed test strip FDA UDI

Identifiers

Catalog Number: 3S-01-14003Y FDA UDI
Primary DI / UDI-DI: 04711200722840 FDA UDI
510(k) Number: K032985 FDA UDI
FDA Product Code: CGA FDA UDI
NBW FDA UDI
GMDN Term: Glucose monitoring system 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

Yes

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

Yes

FDA UDI

Category: Glucose monitoring system IVD, home-use

GlucoLeader Enhance Blood Glucose vial packed test strip 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, home-use.

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Cleared under the same submission

K032985 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 a4c9240d-07e5-4470-8a71-7f224ff03e0c 35 fields · synced Jun 8, 2026
EUDAMED 1 fields · synced May 29, 2026