BEUDAMED
    230 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Country: China × Clear all

    MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems China Co., Ltd.·June 10, 2026

    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

    Philips Incisive CT

    FDA Enforcement
    Class II ·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 14, 2026

    Menopause Test Cassette (Urine)

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

    BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F

    FDA Enforcement
    Class II ·Ongoing·HANGZHOU BEVER MEDICAL DEVICES CO., LTD.·January 21, 2026

    Material Processing Laser Products

    FDA Enforcement
    Class II ·Ongoing·SHENZHEN ATOMSTACK TECHNOLOGIES·January 7, 2026

    Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Pluslife Biotech Co., Ltd.·June 25, 2025

    Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Pluslife Biotech Co., Ltd.·June 25, 2025

    Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

    FDA Enforcement
    Class II ·Ongoing·Zhejiang Luyao Electronics Technology Co., Ltd.·September 3, 2025

    Bodor's I series laser cutting machine.

    FDA Enforcement
    Class II ·Ongoing·Jinan Bodor Cnc Machine Co Ltd·July 30, 2025

    GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025