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Rosie SmartMeter Test Strips 50ct(vial)

FDA UDI

Class II (US FDA UDI)

by Hmd Biomedical, LLC

Identity

Trade Name
Rosie SmartMeter Test Strips 50ct(vial) FDA UDI
Generic Name
Glucose monitoring system IVD, point-of-care FDA UDI
Device Name
Rosie SmartMeter Blood Glucose GDH-FAD Test Strips FDA UDI
Model / Reference
3S-01-16003A FDA UDI
Description
Rosie SmartMeter Blood Glucose GDH-FAD Test Strips FDA UDI

Identifiers

Catalog Number
3S-01-16003A FDA UDI
Primary DI / UDI-DI
00868665000076 FDA UDI
510(k) Number
K113307 FDA UDI
FDA Product Code
LFR FDA UDI
JJX FDA UDI
NBW FDA UDI
GMDN Term
Glucose monitoring system IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.1660 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Over-the-Counter

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Rosie SmartMeter Test Strips 50ct(vial) by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K113307 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hmd Biomedical, LLC

Sources (1)

  • FDA UDI 03078833-f1dc-431f-a9c8-800e90adab47 38 fields · synced May 30, 2026