Regulatory information & IFU request
This page provides product-related regulatory information for CarbonAid® and CarbonMini®. The information is intended for healthcare professionals and distribution partners.
Product availability, indications, regulatory status and approved uses may vary between countries and regions according to local regulatory requirements.
Legal manufacturer
Gustavslundsvägen 143, 5 tr
167 51 Bromma
Sweden
Products
- CarbonAid®
- CarbonMini®
Instructions for Use
The current Instructions for Use are supplied with each device.
Healthcare professionals must always consult the current Instructions for Use, product labelling and applicable local regulatory documentation before using CarbonAid® or CarbonMini®.
Current Instructions for Use are available on request. Requests may be submitted through the contact form on this website or by contacting Cardia Innovation AB directly.
Printed copies can be provided upon request.
Request current IFUPlease state the subject in your message: IFU request – CarbonAid / CarbonMini
Quality management system
Cardia Innovation AB operates under an ISO 13485 certified quality management system.
Regulatory status
CarbonAid® and CarbonMini® are CE-marked medical devices.
The devices are currently marketed in the EU under MDD legacy certification during transition toward MDR.
In the United States, CarbonAid® and CarbonMini® have FDA 510(k) clearance.
Regulatory status, availability and approved uses may vary by country or region.
Adverse events and product complaints
Healthcare professionals should report adverse events or product complaints related to CarbonAid® or CarbonMini® to Cardia Innovation AB and/or the competent authority in their country in accordance with applicable local requirements.
Contact CardiaImportant notice
The information on this page is provided for regulatory and product-information purposes.
It does not replace the current Instructions for Use, product labelling, clinical judgement, local procedures or applicable regulatory requirements.
Clinical decisions remain the responsibility of the treating physician or surgical team.