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Healthcare and visitor isolation gown (export entry) · ST-010

Worn by healthcare personnel or visitors as a barrier when in contact with patients. This certificate is an export-only entry.

Project record

Case reference
ST-010
Target market
Australia
Product class
MD Class I · Export Only
Our team's work
Submitted on behalf of clients
Evidence basis
Retained certificate, 1 page

What similar projects should consider

Similar products can have different uses, models and applicant entities. Assess the specific documentation for each project.

Individual products still require assessment of intended use, model scope and technical documentation. This case does not replace product-specific classification.

Certificate preview

Grey areas conceal manufacturer and client information. The document below contains all pages with text and images redacted.

Open the complete redacted certificate (PDF · 1 page)Healthcare and visitor isolation gown (export entry) · ST-010: redacted certificate first page

Discuss your product registration project

Provide intended use, existing authorizations and launch plans so we can assess preparation and support needs.