information of the company itself
Optaline for Medical Devices
Block 285 - Zone D East Industrial – 11829 – Badr City, Egypt
www.optaline.com
Contact person:
Mahmoud Fayez, General Manager, +20-1013318885,
m.fayez@optaline.com
Mahmoud Foad, Quality Manager, +20- 1008623836,
mfoaad@optaline.com
Shullammith Magdy, QA Manager, +20-1222283927,
shullammith.anwar@optaline.com
do you manufacture the device
Yes, Optaline is a manufacturer.
how many employees
15 employees
when the technical file will be available
Within 3 months
Injector
what are your codes under MDR
requested annexe s
Micro sponge
MDN 1206
MDN 1208
MDN 1214-1
MDS 1005-1
MDT 2001
MDT 2002
MDT 2008
MDN 1204
MDN 1206
MDN 1208
MDN 1211
MDN 1214-1
MDS 1005-4
MDT 2002
MDT 2004
MDT 2008
Regulation (EU) 2017/745 Annex IX Chapter I, III and Section 4
Injector
Blades
(Keratome)
Micro sponge
OptaJect
OptaEdge
OptaSpear
The intended use is to be
used as an Intraocular
Lens delivery system for
the surgery of Cataract
The instrument is
used to make initial
corneal and sclera
incision before
surgery.
Eye spears are used in
ophthalmic or microscopic
surgical procedures to
absorb excess fluids from
the operative site.
Risk Class
Class IIa
Class IIa
Class IIa
Classification rules
Rule 6.1
Rule 6.1
Rule 4.3
Trade Name
information about the
device itself how does it
work
MDN 1202
MDN 1206
MDN 1208
MDN 1214-1
MDS 1005-1
MDT 2002
MDT 2008
Blades
(Keratome)
Intended Use