DRAP REGISTERED MEDICAL DEVICE
CARTO 3 System [FG540000U] is registered with DRAP under number MDIR-0001421 as a Class B (low to moderate risk) medical device, imported. The listed holder is Johnson & Johnson Pakistan (Pvt) Ltd. Its listed renewal date (12 Apr 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001421 · the class is taken from DRAP's list for this number
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-00154
| Device | CARTO 3 System [FG540000U] |
|---|---|
| Class | B |
| Listed holder | Johnson & Johnson Pakistan (Pvt) Ltd |
| Holder address | Office No, 806, 8th Floor Horizon Towers, Block 3, Scheme No 5, Clifton, Karachi. |
| Manufacturing site | M/s Biosense Webster, Inc 33 Technology Drive Irvine, CA USA, 92618 M/s Biosense Webster, Inc 15715 Arrow Hwy, Irwindale, CA USA. 91706 |
| Issued | 13 Apr 2020 |
| Renewal date | 12 Apr 2025 |
| Licence | ELI-00154 |
Specifications
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Screened 6 Oct 2026, 14:06 (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.
