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Fora

FDA UDI

Class II (US FDA UDI)

by Fora Care Inc.

Identity

Trade Name
FORA FDA UDI
Generic Name
Glucose monitoring system IVD, point-of-care FDA UDI
Device Name
Multi-Functional Monitoring System FDA UDI
Model / Reference
Test N'GO Advance Pro FDA UDI
Description
Multi-Functional Monitoring System FDA UDI

Identifiers

Primary DI / UDI-DI
00816042013645 FDA UDI
510(k) Number
K161738 FDA UDI
FDA Product Code
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
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Fora by Fora Care Inc. — 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

K161738 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fora Care Inc.

Sources (1)

  • FDA UDI 1d80db19-aca6-4676-9d11-27b859b1e6ac 34 fields · synced May 30, 2026