Certificates

Our company has a contract as a Health Provider with EOPYY which is the Greek National Health Service, for the completion of prescriptions from National Healthcare Providers,

The process you will need to follow in order for the Greek National Health Service to cover a partial cost of the manufacture of the prosthesis is:

• Visit your ophthalmologist and acquire an electronic prescription for a PLASTIC ARTIFICIAL EYE
• The prescription needs to be dated and stamped by an auditing doctor
• Bring it to our lab before it expires

Replacement of an artificial eye can be prescribed legally:

• Until 6 years of age, every 6 months
• Until 12 years of age every year
• Until 18 years of age every 2 years
• Adults every 5 years

Our lab undergoes annual audits of its Quality Control System renewing and maintaining the following certifications

TUV NORD

Certificate: Quality Management system as per
ΙSO 9001: 2015 &

TUV HELLAS

Certificate: Management system as per ELOT EN ISO
13485:16 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes

•  Manufacturing and Sales of Custom Ocular Prosthetics
•  Trade and Distribution of Medical Devices in the field of
  Ophthalmology, 
•  Surgery and Prosthetics
  (Product design is excluded from the Certificate’s scope.)

TUV NORD

Attestation of conformity as per Decision No.1348/04 of the Greek Ministry for Health and Welfare
Scope:
Trade and Distribution of Medical Devices in the field of Ophthalmology,
Surgery and Prosthetics

Other Certifications:

GS1 Association Greece

Certification: Reg. Number 3236

National Organization for Medicines

Reg. Number: ΕΠ 457 05 2020

REGION OF ATTICA DEVELOPMENT AUTHORITY DEPARTMENT

FOLDER NUMBER 39/1467
«Compliance with provided documents for legal Custom Ocular Prosthetics Manufacturing laboratory»