Manufacturer Certifications

What backs the product itself

These certifications belong to our manufacturing partner and travel with every batch we import — they are not claims made by Cottonera KSA as a manufacturer.

ISO 13485:2016

Quality management systems for medical devices — the international benchmark for consistent, controlled production.

CE Registered

Conformity with European health, safety and environmental protection standards.

FDA Registered

Registered with the U.S. Food and Drug Administration for the medical cotton product line.

OMP Certified

Certified organic medicinal processing standards for raw cotton handling.

Cottonera KSA · Local Standing

Registered and accountable in Saudi Arabia

Cottonera KSA operates as a registered Saudi commercial entity, giving hospitals and procurement teams a local counterpart to contract, invoice and audit.

Commercial Registration Certificate
Cottonera KSA · Kingdom of Saudi Arabia
View PDF
TR Textile Products Certificate
Product compliance documentation
View PDF
Manufacturer Scope Certificate
USB00103349MUL2601
View PDF

Full certificate archive available on the Resources page.

Need certificates for a tender submission?

We can provide certified copies and additional documentation on request.

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