DRAP REGISTERED MEDICAL DEVICE
Cobas Elecsys free PSA test kit is registered with DRAP under number MDIR-0000634 as a Class C (moderate to high risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. Its listed renewal date (9 Oct 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000634
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00009
| Device | Cobas Elecsys free PSA test kit |
|---|---|
| Class | C |
| Listed holder | Roche Pakistan Ltd. |
| Holder address | 37-C, Block -6, P.E.C.H.S, Karachi, Godown: R-Pl, Plot No. 56, Sector 15, K.I.A, Karachi |
| Manufacturing site | M/s Roche Diagnostics GmbH Sandhofer Str.116, 68305 Mannheim, Germany |
| Issued | 9 Nov 2019 |
| Renewal date | 9 Oct 2024 |
| Licence | ELI-00009 |
Specifications
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Screened 5 Oct 2026, 12:30 (Pakistan time). A screening aid, not an official DRAP verification.
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| MDIE-0000625 | Cobas Omni Utility Channel Reagent Kit [09052011190] | Class A |
| MDIE-0000626 | Cobas p501 post-analytical unit [05158494001] | Class A |
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Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0001245 | Cobas Elecsys CMV IgM Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001247 | Cobas Elecsys Everolimus Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001248 | Cobas Elecsys Tacrolimus Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001249 | Cobas Elecsys Sirolimus Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001250 | Cobas Elecsys Cyclosporine Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001251 | Cobas Elecsys PAPP-A Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001252 | Cobas Elecsys Anti-HAV Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001253 | Cobas Elecsys sFlt-1 Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001264 | Cobas Elecsys Free bhCG IVD Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001266 | Cobas Elecsys PIGF Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
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.