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 vs UKCA: Three Systems, One Product
A factory can hold several of these at once — and for brands selling across the US, the EU and Great Britain, all three matter:
- FDA (US): cosmetic facility registration + cosmetic product listing under MoCRA. Ask for the FEI number and the Cosmetics Direct submission confirmation.
- CE MDR (EU): technical file + declaration of conformity + UDI. EU importers often ask the Chinese factory to provide these with each shipment.
- UKCA (Great Britain): since Brexit, GB uses UKCA rather than CE. Class I is self-declared, so the artefacts are a per-SKU declaration of conformity plus MHRA manufacturer registration through a UK Responsible Person — and unlike the FDA route, the MHRA register is publicly searchable.
HLK holds FDA cosmetic facility registration (MoCRA), CE MDR, UKCA with MHRA registration for Great Britain, and ISO 13485 — and provides REACH/MSDS/COA with batches — see the certificates page or the UK record.
How to Verify a Factory's EU Paperwork
- Ask for the document itself, not a logo: a certificate with number and issuing body where one exists (ISO 13485, SGS reports), or the signed declaration of conformity for CE and UKCA Class I.
- For CE: request the Declaration of Conformity in the brand owner's name, not just the factory's.
- For FDA: cosmetic registrations are not publicly searchable under MoCRA. Use the FDA FEI Search Portal to confirm the facility has an FEI on file, or ask the supplier for the Cosmetics Direct confirmation.
- For the UK: the MHRA PARD register is open to the public — look the manufacturer up by name and check the registered device types and the named UK Responsible Person against the declaration of conformity.
- 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 documentation, UKCA declaration, FDA cosmetic registration confirmation, ISO 13485 certificate 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.