DRAP REGISTERED MEDICAL DEVICE
Fistula Needle (Rotating Wing)(Dialysis needle) is registered with DRAP under number MDIR-0001821 as a Class B (low to moderate risk) medical device, imported. The listed holder is Fresenius Medical Care Pakistan (Pvt) Ltd.. Its listed renewal date (22 Sep 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001821
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 | Fistula Needle (Rotating Wing)(Dialysis needle) |
|---|---|
| Class | B |
| 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 |
| Issued | 23 Sep 2020 |
| Renewal date | 22 Sep 2025 |
| Licence | ELI-00315 |
Specifications
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Screened 5 Oct 2026, 04:04 (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.
| MDIE-0000734 | DALI Priming Solution 3000 ml Code: F00001513 (Priming Solution) | Class A |
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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 |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0008800 | Safety Flo Fistula Needle | Class B | United Healthcare |
| MDIR-0007810 | Starmed Disposable Fistula Needles | Class B | United Healthcare |
| MDIR-0008374 | Wego A.V. Fistula Needle Set | Class B | K.S Agencies |
| MDIR-0008150 | MED SURG (Disposable AV Fistula Needle) | Class B | M.A Traders |
| MDMR-000467 | Venus Disposable Fistula Needle | Class B | Bioron Medics (Pvt) Ltd. |
| MDIR-0007770 | NephroNeedle Fistula needle set | Class B | Asto Life Sciences (Pvt) Ltd |
| MDIR-0007214 | HMD Disposable Fistula Needle | Class B | Hanson International |
| MDIR-0006771 | A.V. FISTULA NEEDLE SET | Class C | S. Ejazuddin & Co |
| MDIR-0006465 | OCI (Arteriovenous Fistula Needle Sets) | Class B | MOODY Global Services |
| MDIR-0005876 | AV Fistula Needle [SHM-AVFR 15G, SHM-AVFR 16G, SHM-AVFR 17G] | Class B | Spero Enterprises |
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.