Clearblue

FDA UDI

Class I (US FDA UDI)

by Spd Swiss Precision Diagnostics Gmbh

Identity

Trade Name: Clearblue FDA UDI
Generic Name: Natural conception assistance kit FDA UDI
Device Name: Clearblue Ovul Dig 30ct. US FDA UDI
Model / Reference: Digital Ovulation Test FDA UDI
Description: Clearblue Ovul Dig 30ct. US FDA UDI

Identifiers

Primary DI / UDI-DI: 00633472602399 FDA UDI
FDA Product Code: NGE FDA UDI
GMDN Term: Natural conception assistance kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1485 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Natural conception assistance kit

Clearblue by Spd Swiss Precision Diagnostics Gmbh — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Natural conception assistance kit.

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Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) — EASY HEALTHCARE CORPORATION · Class II
Topcare — Topco Associates, LLC · Class I
PREGABLE Ovulation Test Kit — Equinox Biotech Co., Ltd. · Class I
DAVID — Equinox Biotech Co., Ltd. · Class I
Smilereader ovulation test kit — Equinox Biotech Co., Ltd. · Class I
Easy@Home Ovulation Test Strip (50 tests kit) — EASY HEALTHCARE CORPORATION · Class I
Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II

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: Spd Swiss Precision Diagnostics Gmbh

Sources (1)

FDA UDI 23fead6e-4c62-40ab-8716-ecebc2d0d466 35 fields · synced May 30, 2026