StatSensor/StatStrip

FDA UDI

Class I (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name: StatSensor/StatStrip FDA UDI
Generic Name: Glucose monitoring system IVD, point-of-care FDA UDI
Device Name: StatStrip StatSensor Docking Station FDA UDI
Model / Reference: 1.75 FDA UDI
Description: StatStrip StatSensor Docking Station FDA UDI

Identifiers

Catalog Number: 53401 FDA UDI
Primary DI / UDI-DI: 00385480534017 FDA UDI
FDA Product Code: KHP FDA UDI
CGL FDA UDI
CGA FDA UDI
GMDN Term: Glucose monitoring system IVD, point-of-care FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1450 FDA UDI
862.1225 FDA UDI
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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

StatSensor/StatStrip by Nova Biomedical Corporation — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Nova Biomedical Corporation

Sources (1)

FDA UDI 3d30ea78-583d-47e8-8552-29c698088536 35 fields · synced Jun 8, 2026