DRAP REGISTERED MEDICAL DEVICE
4008A (Active Haemodialysis Device) [M202201] is registered with DRAP under number MDIR-0000993 as a Class C (moderate to high risk) medical device, imported. The listed holder is Fresenius Medical Care Pakistan (Pvt) Ltd.. Its listed renewal date (5 Dec 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000993
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-00315
| Device | 4008A (Active Haemodialysis Device) [M202201] |
|---|---|
| Class | C |
| Listed holder | Fresenius Medical Care Pakistan (Pvt) Ltd. |
| Holder address | TAMC, First Floor, 27-C III, M.M. Alam Road, Gulberg III, Lahore |
| Manufacturing site | M/s. Fresenius Medical Care AG & Co KGaA, 61346 Bad Homburg Germany M/s. Fresenius Medical Care Deutschland GmbH Hafenstrabe 9, 97424 Schweinfurt, Germany |
| Issued | 6 Dec 2019 |
| Renewal date | 5 Dec 2024 |
| Licence | ELI-00315 |
Specifications
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Screened 5 Oct 2026, 09:54 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
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| MDIR-0000799 | FX-Class Low-flux Dialysers) (Dialysers / Filters) | Class C |
| MDIR-0000800 | CITROSTERIL (Heat Disinfectant for Haemodialysis Machines with Recirculation) | Class B |
| MDIR-0000984 | BCM (Body Composition Monitor) [H022011] | Class B |
| MDIR-0000985 | Hemoflow HPS (Dialysers / Filters) | Class C |
| MDIR-0000986 | Hemoflow HF (Dialysers /Filters) | Class C |
| MDIR-0000987 | Ci-Ca Dialysate K2 (Dialysate) | Class C |
| MDIR-0000988 | PlasmaFlux (Plasma filters) | Class C |
| MDIR-0000989 | Swan-Neck-Catheter (Peritoneal Dialysis Catheters) | Class C |
| MDIR-0000990 | FX CorDiax (Dialysers / Filters) | Class C |
| MDIR-0000991 | ONLINEplus 5008 (Haemodialysis Device) [M201011] | Class C |
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.