← Back to catalogue

GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT)

FDA UDI

Class II (US FDA UDI)

by Hmd Biomedical, LLC

Identity

Trade Name
GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT) FDA UDI
Generic Name
Glucose IVD, kit, electrometry FDA UDI
Device Name
GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/BMT) FDA UDI
Model / Reference
3S-01-14010J FDA UDI
Description
GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/BMT) FDA UDI

Identifiers

Catalog Number
3S-01-14010J FDA UDI
Primary DI / UDI-DI
04711200722291 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT) by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K182428 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hmd Biomedical, LLC

Sources (1)

  • FDA UDI f5711638-bb88-4841-9b2b-e0f806f90c54 36 fields · synced May 30, 2026