DRAP REGISTERED MEDICAL DEVICE
CoaguChek Pro II (Coagulation Meter Kit) is registered with DRAP under number MDIR-0001270 as a Class C (moderate to high risk) medical device, imported. The listed holder is Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400. Its listed renewal date (5 Feb 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001270
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 | CoaguChek Pro II (Coagulation Meter Kit) |
|---|---|
| Class | C |
| Listed holder | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| Holder address | 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 | 6 Feb 2020 |
| Renewal date | 5 Feb 2025 |
| Licence | ELI-00009 |
Specifications
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Screened 5 Oct 2026, 12:34 (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-0000603 | IVD Instrument BenchMark Ultra System with Accessories | Class A |
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| MDIR-0001245 | Cobas Elecsys CMV IgM Test Kit | Class C |
| MDIR-0001246 | Elecsys HSV-1 IgG Test Kit | Class C |
| MDIR-0001247 | Cobas Elecsys Everolimus Test Kit | Class C |
| MDIR-0001248 | Cobas Elecsys Tacrolimus Test Kit | Class C |
| MDIR-0001249 | Cobas Elecsys Sirolimus Test Kit | Class C |
| MDIR-0001250 | Cobas Elecsys Cyclosporine Test Kit | Class C |
| MDIR-0001251 | Cobas Elecsys PAPP-A Test Kit | Class C |
| MDIR-0001252 | Cobas Elecsys Anti-HAV Test Kit | Class C |
| MDIR-0001253 | Cobas Elecsys sFlt-1 Test Kit | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0004446 | CoaguChek SoftClix Lancet [Code: 03506509001 Size: 50 Lancets] | Class B | Roche Pakistan Ltd. |
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.
