Document Library

Access product documentation, regulatory files, and marketing resources. Some documents require distributor registration or NDA. Public documents are available for immediate download.

Structured Documentation for Every Stakeholder

From your QA/RA team to your sales force — every document is categorized, version-controlled, and access-leveled for clarity.

Product Information

Instructions for use, performance data, and technical product information.

Instructions for Use â€” IFU (PDF) Public
Performance Evaluation Study (PDF) Public

Regulatory & Compliance

CE-IVD certification, declarations of conformity, and regulatory file summaries.

Declaration of Conformity (PDF) Public
Safety Data Sheet (SDS) Distributor
Technical File Summary NDA
Post-Market Surveillance Summary Distributor

Certifications

Regulatory certifications and quality management documentation.

IVD Certificate (PDF) Public
ISO 13485 Quality Certificate (PDF) Public
IVDR Confirmation Letter (PDF) Public
Free Sale Certificate (PDF) Public

Marketing Materials for Partners

Localized marketing assets, product brochures, and sales training materials.

Product Brochure (EN) Distributor
Product Brochures (SE / NO / DK / FI) Distributor
Graphic Assets & Packaging Templates (OEM) NDA
Sales Training Presentation Distributor
Localized Copy Kit Distributor

Access Levels

Level	Who	Access
Public	Anyone	Product sheets, CE certificate, IFU, SDS, brochure (EN)
Distributor	Registered partners	All public + localized materials, training, QMS overview
NDA	Signed NDA partners	Technical file summary, OEM assets, pricing documentation

Need Full Document Access?

Register as a distribution partner to unlock the complete documentation library, including localized materials, training resources, and regulatory files.

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