Application of Council of Directive: 93/42/EEC on Medical Devices Restricted to the Aspects of Manufacture Concerned with Securing and
Maintaining Sterile Conditions.
This Is to Certify That Technical Documentation for The Products:
PRODUCT DESCRIPTION: DISPOSABLE AND NON-DISPOSABLE WOVEN AND NON-WOVEN SUPPLEMENTS (FACE SHIELDS. SURGICAL GOWNS, EXAMINATION GOWNS, APPARELS, UNIFORMS, LAB COATS, SCRUBS, FACE MASKS, OVER HEAD, OVER SHOES, OVER BOOT, BED SHEETS, SURGICAL DRESSES, DENTAL NAPKINS, SURGICAL DRAPE, WOUND DRESSING, PACKS AND COVERALL) STERILE AND NON-STERILE

EL- SAFA FOR THE MEDICAL SUPPLIES INDUSTRY LTD.

Located at
PLATE NO. 183. A6 ROUBAIKY INDUSTRIAL ZONE, 3RD INDUSTRIAL AREA, 10TH OF RAMADAN CITY, ALSHARQIA-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: 15.04. 2025                                1st Surveillance:  15.04. 2026
Certificate Expiry:     15.04. 2028                                2nd Surveillance: 15.04. 2027

Certificate No: QACE20230498