Rosie

FDA UDI

Class II (US FDA UDI)

by Fora Care Inc.

Identity

Trade Name: Rosie FDA UDI
Generic Name: Glucose analyser IVD, point-of-care FDA UDI
Device Name: Blood Glucose Monitoring System FDA UDI
Model / Reference: RealTime FDA UDI
Description: Blood Glucose Monitoring System FDA UDI

Identifiers

Primary DI / UDI-DI: 00816042013287 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose analyser 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

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

FDA UDI

Category: Glucose analyser IVD, point-of-care

Rosie by Fora Care Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Fora Care Inc.

Sources (1)

FDA UDI 485ed87a-e132-41f4-a0b8-7c713450ad29 33 fields · synced Jun 1, 2026