How disposable disinfection products are classified
Under MDR, classification (Class I, IIa, IIb, III) depends on factors such as intended purpose, duration and invasiveness. The class determines whether a manufacturer can self-declare conformity or must involve a notified body. Confirm your product's class with a regulatory advisor — it drives the whole route.
Documentation buyers should request
- Technical documentation (Annex II/III) maintained and available on request.
- EU Declaration of Conformity for each product line.
- EUDAMED registration (the manufacturer's SRN) and an EU Authorised Representative for non-EU manufacturers.
- Underlying quality system: ISO 13485:2016.
What Stripmed provides
Nantong Strip Medical Supply manufactures under ISO 13485:2016, provides an EU Declaration of Conformity for each product line, is registered in EUDAMED with an EU Authorised Representative, and maintains the technical file. Note: the company does not hold a notified-body CE certificate — confirm the CE/conformity route applicable to your product class. See our certifications.
Frequently asked questions
Does EU MDR require CE marking?
Most medical devices placed on the EU market must be CE marked under MDR; the conformity route (self-declaration vs notified body) depends on the device class. Confirm what applies to your product.
What is an EU Authorised Representative?
A person/entity established in the EU that a non-EU manufacturer mandates to act on its behalf for regulatory purposes; it is required to place devices on the EU market.
Do you provide the technical file?
We maintain the technical documentation and provide an EU Declaration of Conformity; the technical file is available on request under NDA.
