Exporting from the United States
Amnion LLC exports its human amniotic membrane allografts from its FDA-registered tissue establishment in Sterling, Virginia. The U.S. Food and Drug Administration has issued Amnion a Certificate to Foreign Government (CT:6XHP-KC9M) covering the AmDisc™ and AmGraft™ product family, certifying that these products may be legally marketed in and exported from the United States. Amnion is accredited by the American Association of Tissue Banks (AATB) and certified to ISO 13485:2016.
Outside the United States, Amnion works through in-country distribution partners who hold the registrations required in their market. Product registration requirements differ by country, and availability in any market depends on completion of that country’s process. A copy of the Certificate to Foreign Government is available to international distributors and regulators on request.
Active Distribution
Canada — WhiteOp
Amnion LLC is registered with Health Canada as a Cells, Tissues and Organs (CTO) establishment, registration CTO100270, covering donor screening, testing and suitability assessment, retrieval, processing, preservation, quarantine, banking, labelling and packaging, and distribution of amniotic membrane.
Amnion allografts are distributed in Canada by WhiteOp. Clinicians and purchasers in Canada should order through WhiteOp rather than the Amnion online store, which does not ship to Canada.
Don’t See Your Country?
Amnion is expanding its international distribution. If Amnion does not yet distribute in your country, or if you are a distributor interested in representing Amnion in your market, contact us. We use these enquiries to prioritise new market registrations and distributor partnerships.
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