Bandtex Grup S.R.L.

Bandtex Grup S.R.L. specialises in sterile surgical drapes and gowns under the Sanrotex Medical brand. These products are designed for single-use in operating rooms and procedural settings, providing barrier protection for patients and healthcare personnel during surgical and clinical interventions. The portfolio includes both disposable drapes and gowns tailored for various medical procedures.

Bandtex Grup S.R.L. is headquartered in Romania. The company’s location in Romania aligns with its focus on manufacturing medical devices that comply with EU regulatory standards, including those applicable to Class I devices.

Bandtex Grup S.R.L.’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registration ensures transparency and compliance with EU Medical Device Regulation (MDR) or prior directives, as applicable to their Class I products.

Bandtex Grup S.R.L.’s devices fall under Class I classification in the EU. This classification is assigned based on risk assessment criteria, where Class I devices are deemed to pose minimal risk to patients and users. As a result, they are subject to general safety and performance requirements but do not require additional conformity assessments beyond basic compliance procedures.