You might like
Sibionics GS1 CGM Continuous Glucose Monitoring
TENS & EMS Muscle Stimulator Therapy
Berflow Health supplies medical devices and healthcare products for home users and professional buyers. For institutional, distributor and government procurement we can provide the supporting documentation buyers require.
Depending on the product, the following can be provided with a quotation or on request: EC Declarations of Conformity and CE marking documentation; manufacturer quality-management certificates (e.g. ISO 13485) where applicable; product datasheets and instructions for use; and lot/batch documentation for consumables and PPE. [Please confirm which certifications apply to which products so we can list them explicitly here.]
Medical devices are regulated differently in each country. Buyers are responsible for any local registration or import authorisation required in the destination market — for example SAHPRA (South Africa), PPB (Kenya), NAFDAC (Nigeria), the FDA (Ghana and the United States) and equivalent authorities elsewhere. We can supply manufacturer documentation to support your registration.
To receive a certifications pack for a specific product or order, request a quote or email hello@berflow.com.
Last updated: [DATE].
