EU Certifications for Nasal Strips: What Importers Must Check
Nasal strips sold in the EU are medical devices. Here's what CE MDR, REACH, ISO 13485 and batch documents actually mean — and how to verify a factory's paperwork before you commit.
The Five Documents That Matter
CE MDR (EU MDR 2017/745)
The CE marking for medical devices under the EU Medical Device Regulation. Nasal strips are typically Class I devices — but the technical file, UDI and declaration of conformity must exist. Ask for the DoC and Notified Body documents, not just a CE logo on a box.
REACH
EU chemical safety regulation. Adhesives and materials in contact with skin must be REACH compliant. A REACH analysis certificate per batch is standard from a serious factory.
ISO 13485
The quality management standard specifically for medical devices. Verify the certificate scope covers medical devices — a generic ISO 9001 does not cover this.
MSDS / SDS
Material Safety Data Sheet covering the adhesive and materials. Required for shipping, customs and EU import documentation.
COA (Certificate of Analysis)
Batch-level test results (adhesion strength, skin-safety, dimensions). A factory that cannot produce a COA per batch is a red flag.
FDA vs CE: Two Systems, One Product
A factory can hold both — and for brands selling in the US and EU, both matter:
- FDA (US): facility registration + device listing. Ask for the FDA registration number and confirm it resolves on the FDA website.
- CE MDR (EU): technical file + declaration of conformity + UDI. EU importers often ask the Chinese factory to provide these with each shipment.
HLK holds FDA registration, CE MDR, ISO 13485 and provides REACH/MSDS/COA with batches — see the certificates page.
How to Verify a Factory's EU Paperwork
- Ask for the certificate PDFs with certificate number and issuing body, then cross-check the issuing body's website.
- For CE: request the Declaration of Conformity in the brand owner's name, not just the factory's.
- For FDA: search the FDA Establishment Registration database for the facility number yourself.
- Request a COA for your exact SKU — a general certificate for "the company" proves less than a batch COA for your product.
- Get a third-party audit (SGS/BV/TÜV) or a factory visit to confirm the certificates match reality.
Need EU-Compliant Nasal Strips?
We'll send you our CE MDR, FDA, ISO 13485 certificates and a batch COA with your sample order.
EU Certification FAQ
Are nasal strips considered medical devices in the EU?
What is the difference between CE MDR and the old CE MDD?
Does HLK provide certificates with every order?
Can a Chinese factory hold CE certification?
More questions? Visit our full FAQ page or contact our team.