BEUDAMED
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    NeoMass AAAC Plus Internal Standard - Labelled Argininosuccinic Acid (ISTD - ASA)

    Device
    EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·On the market

    PÄIV ASA ANNETTU ENNEN SAAPUMISTA

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Oy Apotti Ab·1 device

    NeoMass AAAC Internal standard - Labelled Argininosuccinic Acid (ISTD - ASA)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·1 device

    Siemens Healthcare Oy

    Importer
    🇫🇮 Finland·2 Manufacturers

    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·April 19, 2017

    CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·November 19, 2025

    Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002 CARESCAPE MONITOR B450 B1 2107633-001 CARESCAPE MONITOR B450-GS (V2.0.8) 2094080-001

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·November 19, 2025

    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

    FDA Enforcement
    Class II ·Terminated·Instrumentarium Dental, PaloDEx Group Oy·March 5, 2014

    Kuomed Oy

    Importer
    🇫🇮 Finland·21 Manufacturers