A selective review of the uploaded Saudi licenses, manufacturer authorization and international quality-system certificates most relevant to hospitals, surgeons and procurement teams.
SFDA · EN ISO 13485 · EU MDR QMS
This page intentionally does not publish every uploaded file.
Unsigned templates, expired legacy certificates, internal audit reports, raw test packages and repetitive evidence have been excluded from the public trust layer. Manufacturer certificates shown here belong to STEMA; Aonkor’s own Saudi licenses are identified separately.
The MDMA authorization is limited to the three STEMA Micro System product families listed in its annex.
Product-specific SFDA authorization for the STEMA Micro System plates, mesh and screws listed in the annex.
Current SFDA records identify Aonkor’s authorized-representative, importer/distributor and warehouse activities.
SFDA license naming Aonkor International as the authorized representative for STEMA Medizintechnik GmbH for non-active implantable devices.
SFDA establishment license authorizing Aonkor International to operate as a medical device importer and distributor.
SFDA warehouse license for Aonkor International covering medical devices, IVD products and controlled-temperature products at the licensed Riyadh facility.
These current certificates apply to STEMA and only to the scope described in each official record.
Manufacturer quality-management certification covering development, manufacturing and distribution within the scope stated on the certificate.
STEMA quality-system certification under Regulation (EU) 2017/745 Annex IX for the device scope stated in the certificate.
EN ISO 13485 certification documents the manufacturer’s quality-management scope. The separate EU MDR certificate documents the notified-body quality-system assessment for the device categories stated in that record.
The public record links the manufacturer, the Saudi authorized representative and the covered non-active implantable device category.
Signed manufacturer agreement appointing Aonkor International for authorized-representative responsibilities in Saudi Arabia for the covered device category.
Licenses and certificates are time- and scope-specific. Marketing authorization MDMA-2-2026-2921 covers only the STEMA Micro System plates, mesh and screws listed in its annex. Product availability, indication and documentation should be confirmed for each enquiry.
Request product-specific documentation↗Whether you are equipping a hospital, supporting a surgical department, or looking for premium German medical technologies, Aonkor International is ready to support your clinical and procurement needs across Saudi Arabia.
