Application of Council of Directive: 93/42/EEC on Medical Devices and Medical Requirements Restricted to The Aspects of Manufacture Concerned with Securing and Maintaining Sterile Conditions
This Is to Certify That Technical Documentation for The Products:
DISPOSABIE AND NON DISPOSABIE WOVEN AND NON-WOVEN MEDICAL SUPPLIES (SURGICAL GOWNS, SUPPORTIVE SURGICAL GOWNS, PATIENT GOWNS, EXAMINATION GOWNS, ISOLATION GOWNS, SCRUBS, SURGICAL CAPS, PATIENT PANTS, PATIENT SHORTS, COVERALL, SHOES COVER, BOOT COVER, BED SHEETS, ELASTIC BED SHEETS, BED COVER, FLAT SHEETS, SURGICAL DRESSES, UNDER WEAR SETS FOR WOMEN, SURGICAL DRAPS, PACKS, ARMGUARD, PILLOW COVER, ARPON.) STERILE AND NON STERILE.
SMC FOR INDUSTRY AND TRADE COMPANY.
Located at
3Al Haq Mosque Street, Branch Form The Old Tram, New Tebeen, Tebeen, Helwan,
Cairo, Egypt.
has been assessed and found in accordance with the Requirements of:
The Technical document maintained by the organization has been reviewed and found to comply
with the requirements of Directive: REGULATION (EU) 2017/145 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017Directive 93/42/EEC referred to Medical devices /19 of EU MDR 2017/745 the Annex II + Annex III + Article 19.
This certificate of compliance is based on the technical file of above-mentioned product,
Technical Reports and documentation are at the organization’s, this is to certify that the product is in conformity with all revision of Council Directive 93/42/EEC referred to medical devices.
This certificate does not imply assessment of series production of product and does not permit use of Euro Compliance QAS international. mark of conformity, Further Identification and description of
products covered by this certificate
Certificate Issuance: 04.01.2025 1st Surveillance: 04.01.2026
Certificate Expiry: 04.01.2028 2nd Surveillance: 04.01.2027
Certificate No: QACE20241022