Quality and regulatory
Certified design and manufacturing
UnivLabs designs and manufactures medical devices under an ISO 13485 quality management system.
Certificates
Approvals by market
Tender committees and distributors can download every certificate here.
| Certificate | Scope | Issued by | Valid until |
|---|---|---|---|
| ISO 13485 | [Scope to confirm] | [Certifying body] | [Expiry] |
| CDSCO | [Device classes and licences] | CDSCO, India | [Expiry] |
| CE | [If held: devices covered] | [Notified body] | [Expiry] |
To confirmRegulatory to supply the certificate list, PDFs and expiry dates. Remove any row UnivLabs does not hold.
How we make claims
Every claim within approved intended use
Products are described within their approved intended use. Products in development or research are always labelled as such, and every public claim is reviewed by our Regulatory team.
Need documents for a tender?
Our Regulatory team can provide certificates, declarations and IFUs.