Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), Annex IV
No. V1087008004 REV. 01
This Is to Certify That Full quality assurance system for The Products:
PRODUCTS DESCRIPTION: ALL MICROBILIGICAL (BACTERIAL, FUNGI AND VIRAL)
CULTURE MEDIA DEHYDRATED AND READY FOR USE, ANTIBIOTIC SENSITIVITY DISCS,
ALL LABORATORIES (STAINS, DIAGNOSTIC KITS, CHEMICALS AND INSTRUMENTS).

NOVACULT FOR BIO INDUSTRIES
Located at

DF 4,5,6, Plot no. 207, Third Industrial Area 6th October City, Giza
Governorate, Egypt.

has been assessed and found in accordance with the Requirements of:
We hereby certify that the under mentioned manufacturer has established and maintains a full
quality assurance system according to the requirements of active 98/79/EC on in vitro diagnostic
medical devices (IVDD), Annex IV excluding (4, 6) (list A and B and devices for self-testing)
For the design, manufacturing and final inspection of the products mentioned in the certificate.
Any significant changes in the design or manufacturing may render this certificate invalid.
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 that the aforementioned manufacturer has implemented a
quality assurance system for design, manufacture and final inspection of the respective
devices/device families in accordance with IVDD annex IV. This quality assurance system confirms
to the requirements of this directive and is subjected to periodical surveillance. For marketing of
list devices an additional annex IV (4) certificate is mandatory
QAS international. Mark of conformity, Further Identification and description of
products covered by this certificate.

Certificate Issuance: 18.09. 2025                            1st Surveillance: 18.09. 2026
Certificate Expiry:     18.09. 2028                           2nd Surveillance: 18.09. 2027

Certificate No: QACE020220892