Resources.

The documentation for each line, to download now. The original certificates and the declaration of conformity are sent by email once we confirm the licence.

Data sheets and IFU.

One PDF per document and per language. Data sheet in PT, EN and ES. CE certificate and declaration of conformity: by email, after verification.

Certificates.

CE certificate · 2460Class III, notified body DNV. MDD 93/42/EEC certificates in force under MDR art. 120 until 31 December 2027, with the DNV confirmation letter (C682153). Certificate, letter and declaration of conformity: originals by email, for verified clinics.

ISO 13485The manufacturer's quality management system, medical devices. On file.

Templates and terms.

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