← Back to catalogue

Curo L5

FDA UDI

Class II (US FDA UDI)

by Kpi Healthcare, Inc.

Identity

Trade Name
CURO L5 FDA UDI
Generic Name
Multiple physiological parameter spot-check system analyser FDA UDI
Device Name
CURO L5 Cholesterol and Glucose measuring system FDA UDI
Model / Reference
CURO L5 CURO L5 FDA UDI
Description
CURO L5 Cholesterol and Glucose measuring system FDA UDI

Identifiers

Primary DI / UDI-DI
00860394001225 FDA UDI
510(k) Number
K130295 FDA UDI
FDA Product Code
NBW FDA UDI
CGA FDA UDI
CHH FDA UDI
JGY FDA UDI
JJX FDA UDI
LBR FDA UDI
GMDN Term
Multiple physiological parameter spot-check system analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.1175 FDA UDI
862.1705 FDA UDI
862.1660 FDA UDI
862.1475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose monitoring system IVD, home-useGlucose monitoring system IVD, point-of-careBlood glucose/blood pressure monitoring system, home-useGlucose analyser IVD, home-use

Curo L5 by Kpi Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple physiological parameter spot-check system analyser.

Cleared under the same submission

K130295 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
Kpi Healthcare, Inc.

Sources (1)

  • FDA UDI 032176df-3efc-4201-8480-6a77d8be77cd 34 fields · synced May 30, 2026