Proov

FDA UDI

Class I (US FDA UDI)

by Mfb Fertility, Inc.

Identity

Trade Name: Proov FDA UDI
Generic Name: Natural conception assistance kit FDA UDI
Device Name: A comprehensive at home fertility test that measures four key hormones that impact your cycle and fertility. FDA UDI
Model / Reference: Complete FDA UDI
Description: A comprehensive at home fertility test that measures four key hormones that impact your cycle and fertility. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850035206065 FDA UDI
FDA Product Code: QKE FDA UDI
NGE FDA UDI
NGA FDA UDI
GMDN Term: Natural conception assistance kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1620 FDA UDI
862.1485 FDA UDI
862.1300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Natural conception assistance kit

Proov by Mfb Fertility, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Smilereader ovulation test kit — Equinox Biotech Co., Ltd. · Class I
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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: Mfb Fertility, Inc.

Sources (1)

FDA UDI e355b873-98eb-43d2-a45e-d884bd558898 33 fields · synced Jun 1, 2026