The Directorate General for Energy Planning and Coordination has authorised the modification of the type approval for radioactive devices under the LUM GmbH brand to include the LUMiReader X-Ray 44X model (60 kV, 0.7 mA, and 42 W maximums) (1st). This resolution is issued pursuant to the Regulation on Nuclear and Radioactive Installations (RD 1217/2024) and the Regulation on Health Protection against Ionising Radiation Risks (RD 1029/2022). The authorisation is subject to compliance with strict marking, documentation, and radiological safety specifications (1st, 3rd, and 4th).
For Jover Scientech, SL, acting as the brand representative, this resolution enables the commercialisation of the LUMiReader X-Ray 44X model under approval NHM-X341, provided it adheres to the required indelible marking and technical documentation (3rd and 4th). End users must ensure that the equipment maintains a radiation dose rate not exceeding 1 μSv/h at 0.1 m from the surface (4th.I.c) and must conduct mandatory annual inspections (4th.I.f). This resolution does not replace the necessary licences for manufacturing, commercialisation, or technical assistance in radiological safety (7th).
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