DRAP REGISTERED MEDICAL DEVICE
ISE Calibration Kit is registered with DRAP under number MDIR-0008961 as a Class B (low to moderate risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 9 Apr 2030.
Screening result
MDIR-0008961 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00009
| Device | ISE Calibration Kit |
|---|---|
| Class | B |
| 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 |
| Issued | 10 Apr 2025 |
| Renewal date | 9 Apr 2030 |
| Licence | ELI-00009 |
Specifications
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Screened 6 Oct 2026, 04:27 (Pakistan time). A screening aid, not an official DRAP verification.
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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.