70 results · 20ms · Sources: EU EUDAMED, US FDA

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Vivoo Protein Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Vivoo pH Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Vivoo Vaginal pH Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Menopause Test Cassette (Urine)

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

S. Typhi/Para Typhi A Antigen

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Male Fertility Sperm Test for Home Use (Cassette)

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

LH One Step Ovulation Test Device (Urine)

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

FDA Enforcement
Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

Tianjin New Bay Bioresearch Co., Ltd.

Manufacturer
🇨🇳 China·22 Basic UDI-DIs·22 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Shanghai Moon Bay Medical Instrument Co., Ltd.

Manufacturer
🇨🇳 China

Zhuji Pengtian Medical Instrument Co.,Ltd

Manufacturer
🇨🇳 China·3 Importers

Wuxi Apex Medical Co., Ltd.

Manufacturer
🇨🇳 China

Suretest Precoce

Device
EU IVDD · Eu Ivd Self Testing ·Tianjin New Bay Bioresearch Co., Ltd.·On the market

Digital Ovulation Predictor Test

Device
EU IVDD · Eu Ivd Self Testing ·Tianjin New Bay Bioresearch Co., Ltd.·On the market

Digital 1 Step Pregnancy Test

Device
EU IVDD · Eu Ivd Self Testing ·Tianjin New Bay Bioresearch Co., Ltd.·On the market

Test de grossesse

Device
EU IVDD · Eu Ivd Self Testing ·Tianjin New Bay Bioresearch Co., Ltd.·On the market

Pregnancy Test Strips

Device
EU IVDD · Eu Ivd Self Testing ·Tianjin New Bay Bioresearch Co., Ltd.·On the market