
Coloplast A/S
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COLOPLAST BABY URINE COLLECTORS is an FDA 510(k)-cleared medical device (K833570) manufactured by Coloplast A/S. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 1984. Regulation: 8.