No. The cabinet is strictly classified as "Office Furniture Cabinet" (based on HS Code). It serves purely for logistics and storage purposes and has no therapeutic or diagnostic function. Therefore, it is not subject to the Medical Device Regulation (MDR). It falls under general product safety (GPSR) and specific electronics directives (RED, EMC, LVD).

Since manufacturing takes place in Vietnam, the EU Importer is considered the Distributor. Key obligations include: Acting as the authorized representative within the EU; Keeping the technical documentation available for 10 years; Translating the user manual into the local language (manufacturer provides English version); Registering for WEEE (Waste Electrical and Electronic Equipment) in the destination country.

The device carries the CE Mark and complies with: RED (2014/53/EU) for RFID technology (EN 300 330 / EN 302 208); EMC (2014/30/EU) for electromagnetic compatibility; LVD (2014/35/EU) for electrical safety; RoHS (2011/65/EU) for hazardous substances; and Furniture Safety standards (EN 14073-2/3, EN 14074).

The cabinet is rated IP44. Internal surfaces are powder-coated and resistant to hospital-grade disinfectants (ISO 2812 compliant). Wiping is recommended. Note that the rear panel contains RJ45 and Power connections (24V) and should be cleaned with the same care as a PC or IT equipment (do not soak).

Yes. Under the EU-Vietnam Free Trade Agreement (EVFTA), this product typically enjoys a 0% import tariff. We provide the Certificate of Origin to facilitate this benefit.