Does Styku provide regulatory certifications (CE, ISO 13485, CFS) for international import?
Does Styku provide regulatory certifications (CE, ISO 13485, CFS) for international import?
Regulatory certification requirements vary by country, and Styku's sales team handles these inquiries on a case-by-case basis. If you need documentation such as a CE mark, ISO 13485 certification, or a Certificate of Free Sale (CFS) to legally import or sell a Styku scanner in your market, you will need to contact Styku directly so the sales team can advise on what is available.
What certifications might be required
Depending on your country's regulations, you may need one or more of the following before you can legally import and sell a Styku scanner:
- CE Marking — required for medical or electronic devices sold in the European Economic Area (EEA) and recognized in some other markets
- ISO 13485 — an international quality management standard for medical device manufacturers
- Certificate of Free Sale (CFS) — confirms that a product is legally sold in its country of origin; often required by customs authorities in Southeast Asia and other regions
- Equivalent national certifications — some countries have their own import approval requirements that may accept or require the above as supporting documents
How to submit your certification request
Styku's support team will forward certification inquiries to the sales team, who can tell you which documents are currently available and whether additional certifications can be obtained for your target market.
- Log in to the Styku Business Portal at styku.com/portal.
- Open a support ticket using the ticket form.
- In your ticket, include the following details:
- The Styku scanner model you intend to import
- Your country or region and the specific certification(s) required
- Any regulatory deadlines or import authority requirements you are working with
- Your contact information, including phone and email
A member of the sales team will follow up with you directly.
What to expect
- Support will acknowledge your inquiry and forward it to the Styku sales team.
- The sales team will contact you to discuss which certifications are currently available and what options exist for your market.
- Response time is typically within 1 business day.
If this resolves your issue, no further action is needed.
If the problem persists, contact support and include: the specific scanner model you are inquiring about, the country or region of import, the exact certification names or regulatory authority requirements, and any relevant deadlines.
Applies to: All Styku scanner models; international distributors and businesses with country-specific import certification requirements.