DRAP ENLISTED MEDICAL DEVICE
Cobas b 101 system [06378668190 Pack size: One Unit] is enlisted with DRAP under number MDIE-0000627 as a Class A (low risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 9 Feb 2028.
Screening result
i
Number type: imported, enlisted (Class A only)
MDIE-0000627
MDIE-0000627
✓
Found in DRAP's published list
DRAP enlisted Class A list, 28 Aug 2025
DRAP enlisted Class A list, 28 Aug 2025
✓
Listed valid until 9 Feb 2028
✓
Holder has a DRAP import licence on file
ELI-00009
ELI-00009
| Device | Cobas b 101 system [06378668190 Pack size: One Unit] |
|---|---|
| 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 Str.116, 68305 Mannheim, Germany M/s PHC Corporation Inc. Vitro Diagnostics Division Wakimachi Plant 110 Oaza-Inoshiri-aza-Nishiueno Wakimachi, Mima Tokushima, 779-3603 Japan / Japan |
| Issued | 10 Feb 2023 |
| Renewal date | 9 Feb 2028 |
| Licence | ELI-00009 |
Specifications
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Screened 5 Oct 2026, 12:29 (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-0000629 | Cobas p 701 Post Analytics Unit | Class A |
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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.