ΚΑΡΑΜΠΙΝΗΣ MEDICAL A.E.

ΚΑΡΑΜΠΙΝΗΣ MEDICAL A.E. produces a range of medical devices primarily focused on wound care and examination accessories. These include single-use and reusable examination gloves (nitrile and vinyl, in sizes from small to extra-large), elastic bandages (various widths for compression therapy), water-resistant adhesive strips, and medical tapes (both transparent and metallic) for wound stabilization. The company’s portfolio is designed to support clinical and patient care needs, particularly in hygiene and wound management.

ΚΑΡΑΜΠΙΝΗΣ MEDICAL A.E. is based in Greece, which means its devices are subject to EU Medical Device Regulations (MDR) if marketed within the European Economic Area. The company’s products are registered in EUDAMED, the EU’s medical device registry, indicating compliance with EU requirements. The Greek location also influences regulatory pathways, as devices must meet EU safety and performance standards, particularly for Class I products like those listed.

The company’s devices are listed in EUDAMED, the European Union’s medical device registry. This database is maintained under the EU Medical Device Regulations and serves as an official record of devices that have undergone conformity assessment procedures. Listing in EUDAMED confirms that the devices comply with EU requirements, though it does not imply individual approval—only that they meet regulatory obligations for market placement.

All of ΚΑΡΑΜΠΙΝΗΣ MEDICAL A.E.’s listed devices fall under Class I classification in the EU. This classification applies to low-risk devices like examination gloves, bandages, and medical tapes, which are subject to general safety and performance requirements without additional scrutiny (e.g., clinical evaluations or third-party audits). Class I devices still require compliance with EU MDR, including proper labeling and risk management, but they do not undergo the same rigorous post-market surveillance as higher-risk classes.