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Curo A1c Analyzer

FDA UDI

Class II (US FDA UDI)

by Kpi Healthcare, Inc.

Identity

Trade Name
Curo A1c Analyzer FDA UDI
Generic Name
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI
Device Name
Curo A1c Analyzer FDA UDI
Model / Reference
Curo A1c Analyzer FDA UDI
Description
Curo A1c Analyzer FDA UDI

Identifiers

Primary DI / UDI-DI
00860394001270 FDA UDI
510(k) Number
K082275 FDA UDI
FDA Product Code
CGA FDA UDI
LCP FDA UDI
GMDN Term
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
864.7470 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 A1c Analyzer by Kpi Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose analyser IVD, laboratory, manual.

Cleared under the same submission

K082275 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kpi Healthcare, Inc.

Sources (1)

  • FDA UDI 613c72ec-3e04-4be6-8d57-b99f2533d1b4 34 fields · synced May 31, 2026