EU DECLARATION OF CONFORMITY

Product catalog summary

Declaration Overview: The document is an EU Declaration of Conformity for disposable medical devices, specifically nitrile examination gloves, manufactured by Mooni Ltd. It confirms compliance with EU regulations for medical devices and personal protective equipment.

Manufacturer Details: Mooni Ltd., located in Kowloon, Hong Kong, with an EU Authorized Representative, Mooni International AB, based in Höllviken, Sweden.

Product Specifications: The product is Mooni Multi-Purpose Nitrile Disposable Gloves, non-sterile, powder-free, and ambidextrous. Available sizes are S, M, L, and XL, with specific UDI-DI codes for each size.

Regulatory Compliance: The gloves are classified under Medical Device Regulation (EU) 2017/745 as Class 1 and Personal Protective Equipment Regulation (EU) 2016/425 as Category III-Complex. They are intended to protect against chemical splash and micro-organism hazards and prevent cross-contamination in medical settings.

Certification and Standards: The EU type examination certification is issued by SATRA Technology Europe Limited, Notified Body No. 2777. The gloves conform to several European standards, including EN ISO 374-1:2016, EN 374-4:2013, EN ISO 374-5:2016, EN 420:2003+A1:2009, EN455 series, ISO 14971:2012, and EN ISO 13485:2016.

Conformity Assessment: The PPE undergoes conformity assessment based on internal production control with supervised product checks at random intervals under SATRA's surveillance.

Signatory: The declaration is signed by Staffan Bern, CEO & Founder of Mooni Ltd., on June 11, 2021, in Kowloon, Hong Kong.

Catalog excerpts

mooni. EU DECLARATION OF CONFORMITY We, the undersigned, hereby declare that the disposable device(s) specified below under our sole responsibility meet the provisions of Regulation (EU) 2017/745 on Medical Devices and are in conformance with Regulation (EU) 2016/425 on Personal Protective Equipment

Open the catalog to page 1

EU type examination certification (Module B, Personal Protective Equipment Regulation) issued by: SATRA Technology Europe Limited, Notified Body No. 2777, EU type examination certificate number: 2777/11050-02/E04-01 The PPE is subject to the conformity assessment procedure: Conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) under the surveillance of the SATRA Technology Europe Limited, Notified Body No. 2777. The object of the declaration described is in conformity with the Signed for and on behalf of Mooni Limited Done at Kowloon,...

Open the catalog to page 2

All Mooni catalogs and technical brochures

Mooni EU Declaration of Conformity
3 Pages