AV Fistula Needle [2.1mm
Class B (low to moderate risk) · MDIR-0005878 · Spero Enterprises
DRAP REGISTERED MEDICAL DEVICE
AV Fistula Needle [2.1mm (14G), 1.8mm (15G), 1.6mm (16G), 1.4mm (17G)] is registered with DRAP under number MDIR-0005878 as a Class B (low to moderate risk) medical device, imported. The listed holder is Spero Enterprises. It is listed as valid until 17 Dec 2028.
Screening result
MDIR-0005878 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00600
| Device | AV Fistula Needle [2.1mm (14G), 1.8mm (15G), 1.6mm (16G), 1.4mm (17G)] |
|---|---|
| Class | B |
| Listed holder | Spero Enterprises |
| Holder address | Office No. 301, 3rd Floor, Trade Arcade, 23/F, M.A.C.H.S. Karachi |
| Manufacturing site | M/S Jiangxi hongda medical equipment group LTD 39 south shangli rd jinxian county, Nanchang Jiangxi province China |
| Issued | 18 Dec 2023 |
| Renewal date | 17 Dec 2028 |
| Licence | ELI-00600 |
Specifications
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Screened 7 Oct 2026, 05:37 (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.
| MDIR-0005636 | OEM Spero/ Enttex (Hollow Fiber Dialyser) | Class C |
| MDIR-0005824 | Wesley Dialyzer Reprocessing Machine (Dialyzer Reprocessing Machine) | Class C |
| MDIR-0005876 | AV Fistula Needle [SHM-AVFR 15G, SHM-AVFR 16G, SHM-AVFR 17G] | Class B |
| MDIR-0005877 | Dialysis Blood tubing line [SHM-HBTL-1098AX] | Class B |
| MDIR-0006691 | Blood tubing set for hemodialysis | Class B |
| MDIR-0006692 | Hollow Fiber hemo Dialyser | Class B |
| MDIR-0006693 | Wesley Hemodialysis Machine | 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-0008408 | Fistula Needle (Single Needle) | Class B | Fresenius Medical Care Pakistan (Pvt) Ltd. |
| 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 |
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.