DRAP REGISTERED MEDICAL DEVICE
GENESIS-II (Knee System) is registered with DRAP under number MDIR-0004476 as a Class B (low to moderate risk) medical device, imported. The listed holder is Varitron. It is listed as valid until 1 Jan 2028.
Screening result
MDIR-0004476 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00510
| Device | GENESIS-II (Knee System) |
|---|---|
| Class | B |
| Listed holder | Varitron |
| Holder address | First Floor 60-D, F.C.C. Zahoor Elahi Road, Gulber-IV, Lahore |
| Manufacturing site | M/s Smith & Nephew INC 1450 Brooks Rd, Memphis TN USA 38116 M/s Smith & Nephew Orthopedics (Beijing) Co, Ltd., No. 98, Kechuang Dong Liu Street Beijing Economics-Technological Development Area Beijing, Beijing CHINA 101111 M/s SMITH & NEPHEW ORTHOPAEDICS, GmbH ALEMANNENSTRASSE 14 TUTTLINGEN, Baden-Wurttemberg GERMANY 78532 |
| Issued | 2 Jan 2023 |
| Renewal date | 1 Jan 2028 |
| Licence | ELI-00510 |
Specifications
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Screened 5 Oct 2026, 15:00 (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.
| MDIR-0004475 | LEGION (Revision Knee System) | Class D |
| MDIR-0004477 | ULTRABUTTON (Adjustable Fixation device) [72290003] | Class C |
| MDIR-0004539 | PALACOS MV+G (Medium viscosity, radiopaque Bone Cement with gentamicin) | Class D |
| MDIR-0004979 | Litho (Surgical Laser) [35W] | Class C |
| MDIR-0005119 | Cyber Ho 60 Cyber Ho 100 Cyber Ho 150 (Multicavity Holmium Laser System) | Class C |
| MDIR-0005120 | LITHO EVO (Surgical Laser) | Class C |
| MDIR-0005151 | Anthem Knee System | Class D |
| MDIR-0005280 | Fast Fix 360 (Meniscal Repair System) [IMPLANTS: 72202467, 72202468, 72202469 INSTRUMENTS: 72202674, 72202675] | Class C |
| MDIR-0005598 | Fiber Dust (Surgical Laser) [PFMS00005] | Class C |
| MDIR-0006374 | Swan-Ganz Thermodilution Catheter | Class D |
| MDIR-0006591 | HemoSphere (Hemosphere Advance Monitoring Platform) | Class C |
| MDIR-0006592 | Biorci HA (Bio absorbable Screws) | Class D |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0007891 | Genesis Malleable Penile Prosthesis | Class C | F.W Distributors |
| MDIE-0000094 | Genesis (Sterile Tube Welder) Code: TCDB40 | Class A | Hospicare Systems |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.