11 results
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96ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Vivoo Protein 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
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
Male Fertility Sperm Test for Home Use (Cassette)
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
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
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
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
LH One Step Ovulation Test Device (Urine)
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