Clearblue

FDA UDI

Class I (US FDA UDI)

by Spd Swiss Precision Diagnostics Gmbh

Identity

Trade Name: Clearblue FDA UDI
Generic Name: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Device Name: A convenience kit consisting of 30 Advanced Digital Ovulation tests + 2 Rapid Detection pregnancy tests FDA UDI
Model / Reference: Advanced Digital Ovulation Test Kit FDA UDI
Description: A convenience kit consisting of 30 Advanced Digital Ovulation tests + 2 Rapid Detection pregnancy tests FDA UDI

Identifiers

Catalog Number: N/A FDA UDI
Primary DI / UDI-DI: 00633472602405 FDA UDI
FDA Product Code: NGE FDA UDI
LCX FDA UDI
GMDN Term: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1485 FDA UDI
862.1155 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

FDA UDI

Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Natural conception assistance kit

Clearblue by Spd Swiss Precision Diagnostics Gmbh — 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
Easy@Home Ovulation Test Strip (50 tests kit) — EASY HEALTHCARE CORPORATION · 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: Spd Swiss Precision Diagnostics Gmbh

Sources (1)

FDA UDI da83d0fc-e5fa-4a1d-81d2-48fd6e2df99d 36 fields · synced May 30, 2026