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    PHC Europe B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    MedEnvoy Global BV

    Importer
    🇳🇱 Netherlands·234 Manufacturers

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices