Verified registrations, certifications & global track record

Changzhou DSB Medical Co., Ltd. is a medical device manufacturer of incontinence care products and drug delivery devices. The registrations and certifications below are the verifiable evidence behind our compliance standard.

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U.S. FDA Establishment Registration

Registration number 3008850249 — active U.S. FDA establishment registration with device listings.

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FDA 510(k) Premarket Notification

Clearance K211042 (traditional 510(k), Changzhou DSB Medical Co., Ltd.). View official reference.

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ISO 13485 Quality Management

Certified ISO 13485 quality management system supporting consistent design, manufacturing and distribution of medical devices.

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CE Marking

CE marking applied on applicable product lines within the relevant European Union regulatory scope.

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International Exhibitions

Regular exhibitor at MEDICA (Düsseldorf, Germany) and CPHI (global pharmaceutical and ingredient exhibition).

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OEM / ODM Capability

Full-chain OEM/ODM manufacturing across male external catheters, urine collection bags and soft mist inhalers (SMI).

Buying & compliance guides

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How to Choose a Male External Catheter

Sizing, adhesion and care guidance for external catheter selection.

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How to Measure for a Condom Catheter

Step-by-step sizing method to ensure a secure, comfortable fit.

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Male External Catheter Manufacturer

DSB Medical as a China-based manufacturer and supplier.

Need regulatory documents?

Request certificates, declarations of conformity or a product registration pack.

Contact DSB Medical

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