DRAP REGISTERED MEDICAL DEVICE
Elecsys HE4 is registered with DRAP under number MDIR-0004697 as a Class C (moderate to high risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 13 Feb 2028.
Screening result
MDIR-0004697
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00009
| Device | Elecsys HE4 |
|---|---|
| Class | C |
| Listed holder | Roche Pakistan Ltd. |
| Holder address | 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400, 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 | 14 Feb 2023 |
| Renewal date | 13 Feb 2028 |
| Licence | ELI-00009 |
Specifications
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Screened 5 Oct 2026, 04:45 (Pakistan time). A screening aid, not an official DRAP verification.
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Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0003106 | Elecsys Anti SARS-CoV 2 S Test Kit (Anti Body Kit) | Class C | Roche Pakistan Ltd |
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| MDIR-0001246 | Elecsys HSV-1 IgG 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 |
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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.