Due to the prevailing Corona pandemic, the demand for oral protection is high. Fyndiq takes product safety very seriously and especially during these times. Therefore, there are extra strict guidelines on these products.
Product requirements and related documentation
Fyndiq verifies that the following product-related requirements are met:
- Mouth and respiratory protection must be CE marked
- Personal protective equipment category III must bear the CE marking with the Notified Body's four-digit ID number. Respiratory protection eg shall be marked CE0000
- The Declaration of Conformity, or an URL where it can be downloaded, should be included with the product. The DoC must be in Swedish or English
- The products must be accompanied by a user manual in Swedish or English
- The manufacturer must have provided mouth and respiratory protection with type number, serial number or other identification mark. If this is not possible due to the size or nature of the personal protective equipment, the information must be placed on the packaging or in a accompanying document
- Contact information to the current manufacturer and importer must be on the mouth and respiratory protection, alternatively on the packaging or in the accompanying document
- EU Type-Examination Certificate: Only for categories II and III.
- To be able to sell Category II or III personal protective equipment, the manufacturer must compile technical documentation for the protection and submit a prototype for EU type control to a Notified Body. A Notified Body is an independent organization with the expertise to assist and monitor the manufacturers' work to verify that the products placed on the market comply with the EU / EEA rules. The notified body reviews the technical documentation and tests the product, usually with the help of a harmonized standard. If the protection complies with the requirements of the Personal Protective Equipment Regulation, the notified body issues an EU Type-Examination Certificate.
The following conditions must also be met in order to sell mouth protection and respiratory protection at Fyndiq:
- No information that the mouthguards protect against Coronavirus / virus / pandemics
- No information about "surgery", "medical"
- We do not allow unreasonable pricing
- CE documentation may not be uploaded in the advertisements.