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 OXYGEN MASKS (ADULT, CHILDREN, NEW BORN),
NEBULIZER MASKS (ADULT, CHILDREN, NEW BORN), AIR WAYS (ALL SIZES), CANNULA
NASAL (ADULT, CHILDREN, NEW BORN), MANUAL RESUSCITATOR, ENDOSCOPY TEETHER,
BREATHING TRAINING DEVICE, ANESTHESIA CIRCUITS, BREATHING CIRCUITS,
AND BREATHING BAGS). DISPOSABLE AND NON-DISPOSABLE WOVEN AND NON-WOVEN
MEDICAL SUPPLEMENTS (COMPRESSION BANDAGE, MEDICAL GAUZE, MEDICAL COTTON,
MEDICAL SPARE PARTS AND ABDOMINAL PADS, SURGICAL GOWNS, EXAMINATION GOWNS,
FACE MASK, OVER HEAD, OVER SHOES, BED SHEETS, SURGICAL
DRESSES, SURGICAL DRAPE, PACKS AND COVERALL) STERILE AND NON-STERILE.
ISAMOY FOR MEDICAL SUPPLIES, IMPORT AND EXPORT
Located at
UNIT NO. 1208, PLOT NO. 140, CARNIVAL COMPLEX, THIRD INDUSTRIAL AREA, 6TH OF OCTOBER CITY, GIZA GOVERNORATE – 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: 93/42/EEC on Medical Devices
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: 13.07. 2023 1st Surveillance Done on: 13.07. 2024
Certificate Expiry: 13.07. 2026 2nd Surveillance: 13.07. 2025
Certificate No: QACE20230497