DRAP ENLISTED MEDICAL DEVICE
NGENUITY 3D Visualization System [Adv NGENUITY 1.3 4K OLED Code: 8065753091] is enlisted with DRAP under number MDIE-0000656 as a Class A (low risk) medical device, imported. The listed holder is Medzntech (Pvt) Ltd. It is listed as valid until 2 Apr 2028.
Screening result
MDIE-0000656
DRAP enlisted Class A list, 28 Aug 2025
ELI-00657
| Device | NGENUITY 3D Visualization System [Adv NGENUITY 1.3 4K OLED Code: 8065753091] |
|---|---|
| Class | A |
| Listed holder | Medzntech (Pvt) Ltd |
| Holder address | D-21, Sector 16-A, Govt. Teachers Co-Operative Houseing Society, K.D.A Scheme-33, Karachi |
| Manufacturing site | M/s Alcon Laboratories Inc. 6201 South Freeway Fort Worth, Texas USA 76134 M/s Alcon Research LLC 15800 Alton Parkway, Irvine, CA 92618 M/s Alcon Research LLC 6201 South Freeway Fort Worth TX USA 76134 M/s EMBEDTEK LLC N7W23700 Bluemound Rd Ste 100 Waukesha, WI USA 53188 |
| Issued | 3 Apr 2023 |
| Renewal date | 2 Apr 2028 |
| Licence | ELI-00657 |
Specifications
No supplier specifications yet.
Supplier of this device? Add specifications (free during launch)
Sign in or create a free account to add specifications.
Screened 5 Oct 2026, 12:11 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIE-0000652 | LuxOR Revalia (LX3 LED) Ophthalmic Microscope System Ophthalmic surgical microscope | Class A |
| MDIE-0000653 | LuxOR LX3 Enhanced Ophthalmic Microscope System Ophthalmic surgical microscope | Class A |
| MDIE-0000654 | LuxOR LX3 Ophthalmic Microscope System Ophthalmic surgical microscope | Class A |
| MDIE-0000655 | LuxOR Ophthalmic Microscope Foot Controller | Class A |
| MDIE-0000657 | NGENUITY 3D Visualization System [NGENUIY 1.4 System 8065000113]. | Class A |
| MDIR-0004341 | PUREPOINT Laser System General/Multiple Surgical frequency doubled solid state laser system [8065750597] | Class C |
| MDIR-0004342 | WAVELIGHT OCULYZER II Eye anterior segment analyzer with height adjustable table [8065990793] | Class C |
| MDIR-0004343 | LAUREATE WORLD PHACO SYSTEM Cataract Lens Extraction Surgical Instrument [8065750502] | Class C |
| MDIR-0004384 | LEGION SYSTEM [Cataract Lense Extraction Instrument] | Class C |
| MDIR-0004409 | CONSTELLATION* Vision System Multifunctional Surgical Instrument for anterior & posterior segment ophthalmic surgeries | Class C |
| MDIR-0004410 | INFINITI vision system with accessories and parts Phacoemulsification system | Class C |
| MDIR-0004411 | WAVELIGHT ANALYZER II (with diagnostic table) [Automated ophthalmic refractometer with height adjustable table] [8065990835] | Class C |
Corrections
Is something on this page wrong? Report a correction
Corrections are checked against the evidence before anything changes on this page.
Screen another number
Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.
