DRAP REGISTERED MEDICAL DEVICE
PFC SIGMA RP-F total knee prosthesis (Tibial inserts) is registered with DRAP under number MDIR-0005810 as a Class D (high risk) medical device, imported. The listed holder is Johnson & Johnson Pakistan (Pvt) Ltd. It is listed as valid until 7 Nov 2028.
Screening result
MDIR-0005810 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00154
| Device | PFC SIGMA RP-F total knee prosthesis (Tibial inserts) |
|---|---|
| Class | D |
| Listed holder | Johnson & Johnson Pakistan (Pvt) Ltd |
| Holder address | Office No. 506, 5th Floor, Horizon Tower, Block 3, Scheme No 5, Clifton, Karachi. |
| Manufacturing site | M/s Depuy International Ltd St Anthony's Road, Leeds, LS13. 8D, United Kingdom M/s Johnson & Johnson Medical (Depuy Suzhou) Ltd., No. 299, Changyang Street Suzhou Industrial park, Suzhou, Jiangsu China Z15126 M/s Depuy International Ltd Depuy Ireland Loughbeg, Ringaskiddy, Co. Cork, Ireland M/s DePuy Orthopaedics Inc. 325 Paramount Drive Raynham, MA 02767 USA. M/s Vesta Inc. 9900 South 57th Street, Franklin, Wisconsin, 53132, USA M/s Paragon Medical, Inc 8 Matchett Drive, Pierceton, Indiana, 46562, USA. M/s Symmetry Medical Manufacturing, Inc., 486 West 350 North Warsaw, Indiana, ... |
| Issued | 8 Nov 2023 |
| Renewal date | 7 Nov 2028 |
| Licence | ELI-00154 |
Specifications
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Screened 6 Oct 2026, 06:00 (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.
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| MDIE-0000613 | Cement Restrictor (Accessories) | Class A |
| MDIE-0000614 | S-ROM NOILES (S-ROM Hinge Femoral Instruments) | Class A |
| MDIE-0000615 | Limb Preservation System [LPS] Instruments | Class A |
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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.