BEUDAMED
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    EU MDR · Eu Md Class 1 ·Unique Perspectives Limited·2 devices

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    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Unique Perspectives Limited·2 devices

    ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·February 13, 2019

    ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·February 13, 2019

    European Healthcare & Device Solutions Ltd.

    Authorized representative
    🇮🇪 Ireland·66 Manufacturers·867 Devices

    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    Alinity i Estradiol Reagent Kit, List Number 07P5020

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    RX Series Copper (Cu) Assay Ref. Number CU2340

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·February 14, 2024

    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Progesterone Reagent Kit, List Number 08P3620

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Free T4 Reagent Kit, List Number 07P7030

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i TSH Reagent Kit, List Number 07P4830

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·August 14, 2019

    Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·January 3, 2018

    Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.

    FDA Enforcement
    Class II ·Terminated·Cook Ireland Ltd.·September 12, 2012

    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

    FDA Enforcement
    Class II ·Terminated·Aerogen Ltd.·October 29, 2014

    Sahajanand Medical Technologies Ireland Limited

    Manufacturer
    🇮🇪 Ireland·176 Basic UDI-DIs·176 Devices·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS