DRAP ENLISTED MEDICAL DEVICE
IVD System of Cobas b221 Analyzer with accessories is enlisted with DRAP under number MDIE-0000708 as a Class A (low risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 22 Jun 2028.
Screening result
MDIE-0000708
DRAP enlisted Class A list, 28 Aug 2025
ELI-00009
| Device | IVD System of Cobas b221 Analyzer with accessories |
|---|---|
| Class | A |
| Listed holder | Roche Pakistan Ltd. |
| Holder address | 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| Manufacturing site | M/s Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany M/s Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany |
| Issued | 23 Jun 2023 |
| Renewal date | 22 Jun 2028 |
| Licence | ELI-00009 |
Specifications
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Screened 4 Oct 2026, 22:10 (Pakistan time). A screening aid, not an official DRAP verification.
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| MDIE-0000626 | Cobas p501 post-analytical unit [05158494001] | Class A |
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| MDIE-0000628 | Cobas PCR Urine | Class A |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIE-0000604 | Cobas C111 Analyzer (Without ISE) | Class A | Roche Pakistan Ltd |
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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.
