Thursday March 27, 2025
Product Names: Rollens Platinum Gray, Rollens Plus Platinum Gray, Rollens Gold, Rollens Foam Platinum Gray, Rollens Foam Plus Platinum Gray
Product Designation: Post Mydriatic Safety Glasses
SRN: US-MF-000045283, EORI: PTUS0002453
Basic UDI-DI: 08600124700
Manufacturer: Rollens Professional Products, 15350 E. Hinsdale Dr., Ste. H, Centennial, CO USA.
Authorized Representative: Comply Express Unipessoal LDA, StartUp Maderia, EV141, Campus da Penteada, 9020-105 Funchal, Madeira, Portugal
We declare, under our sole responsibility, that the product listed on this declaration conforms to the provisions of:
CE Medical Device Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 and PPE Regulation (EU) 2016/425 of the European Parliament and the Council of 9 March 2016 and that the fulfillment of the applicable essential health and safety requirement set out in Annex II of 2016/425 have been demonstrated.
Harmonized standards: BS EN ISO 12311, and BN ES ISO 12312-1
Notified Body: Not required.
Conformity Assessment Procedure: Not required
Medical Risk Class: Class I (non-sterile, non-measuring, Single use)
Personal Protective Equipment Category: Category 1
Technical Documentation File maintained at: Rollens Professional Products, 15350 E Hinsdale Dr., Ste. H, Centennial, CO USA. Website: www.Rollens.com
Sincerely,
Dan Salmore
President
The Rollens Company
All Rollens products are made in the U.S.A.
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Rollens is a Veteran-owned business.