Regulatory Compliance & FDA Registration

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Male External Catheter Guide

Verified registrations, certifications, and global exhibition track record.

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Regulatory Compliance

Changzhou DSB Medical Co., Ltd. is a medical device manufacturer of incontinence care products and drug delivery devices. This page documents DSB Medical's regulatory registrations, certifications, and international exhibition track record, providing verifiable evidence of our compliance standard.

U.S. FDA Registration

Establishment Registration Number: 3008850249 — active U.S. FDA establishment registration with device listings.
510(k) Premarket Notification: K211042 (traditional 510(k), Changzhou Dsb Medical Co., Ltd.).
Official reference: FDA 510(k) K211042

ISO 13485

DSB Medical holds ISO 13485 certification for its medical device quality management system, supporting consistent design, manufacturing, and distribution of medical devices.

CE Marking

CE marking is applied on applicable product lines per the relevant regulatory scope.

International Exhibitions

MEDICA — the world's largest medical trade fair, Düsseldorf, Germany.
CPHI — the global pharmaceutical and ingredient exhibition.

OEM / ODM Capability

DSB Medical supports OEM/ODM manufacturing across its product range, including male external catheters, urine collection bags, and SMI soft mist inhalers.

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