Quality Certificates and Regulatory Certificates
Below are convenient links to our current Quality and Product Certificates. Don’t hesitate to contact us if you need further documentation. One of our Regulatory Associates will help you with any documentation needs.
Quality Certificate
Our Quality Certificate is issued by British Standards Institute, which has been our Notified Body since 2014.
CE Certificate
Our CE Certificate includes all the products that we offer in the European Union and is issued by British Standards Institute.
CB Report for CataPulse
The CB Report for the CataPulse is issued by Intertek.
EMC Certificate for CataPulse
The EMC Certificate for the CataPulse is issued by Intertek.
CataPulse Operations Manual
The Operator’s manual is a guide to the CataPulse® Lens Removal & Anterior Vitrectomy System and describes all options available to the user.
ML7 Operations Manual
The ML7® Microkeratome is used to perform lamellar keratoplasty procedures. This procedure is performed by refractive surgeons to create a thin circular corneal cap.
ML7020 MED-LOGICS Blade for use with the Moria® CBm-ALTK Microkeratome
The MED-LOGICS ML7020 CLB® is a SINGLE USE blade designed to cut a precise corneal cap when used with the Moria® CBm-ALTK microkeratome.
ML7030 MED-LOGICS Blade for use with the Nidek® MK-2000 Keratome System
The MED-LOGICS ML7030 CLB® is a SINGLE USE blade designed to cut a precise corneal flap when used with the Nidek® MK-2000 Keratome system.
ML7050 MED-LOGICS Blade for use with the Moria® M2 Microkeratome
The MED-LOGICS ML7050 CLB® is a SINGLE USE blade designed to cut a precise corneal flap when used with the Moria® M2 microkeratome.
ML7061 MED-LOGICS Blade for use with the MED-LOGICS ML7061 Metal Head
The MED-LOGICS ML7061 CLB® is a SINGLE USE blade designed to cut a precise corneal flap when used with the Moria® LSK ONE microkeratome.
ML7070 MED-LOGICS Blade for use with the Hansatome™ Microkeratome
The MED-LOGICS ML7070 CLB® is a SINGLE USE blade designed to cut a precise corneal flap when used with the Hansatome® microkeratome.
ML7071 MED-LOGICS Blade for use with the Zyoptix® Handpiece
The MED-LOGICS ML7071 CLB® is a SINGLE USE blade designed to cut a precise corneal flap when used with the Zyoptix® Handpiece.
ML7090 MED-LOGICS Blade for use with the Amadeus® I & II Microkeratome
The MED-LOGICS ML7090 CLB® is a SINGLE USE blade designed to cut a precise corneal flap when used with the Amadeus® I & II microkeratome.
ML7100 MED-LOGICS, Inc.® blade for use with the ML7® & NiTRO™ Microkeratome
The MED-LOGICS, Inc.® ML7100 CLB® is a SINGLE USE blade designed to cut a precise corneal flap when used with the ML7® & NiTRO™ microkeratome.
ML8001VS Vacuum Tubing Set
The ML8001VS Vacuum Tubing Set is a sterile, disposable, single-use device for use with the Hansatome®, Amadeus® I & II, or ACS microkeratomes.
ML8060VS Vacuum Tubing Set
The ML8060VS Vacuum Tubing Set is a sterile, disposable, single-use device for use with the e MED-LOGICS, Inc.®, ML7 and Moria® LSK ONE, CB, AND M2 Microkeratomes.
ML100 Clean-Compressed PVA Eye Spears
The CleanTouch PVA Eye Spears are sterile, single-use devices designed to absorb excess fluids on the human eye.