DRAP REGISTERED MEDICAL DEVICE
Dialysis Blood tubing line [SHM-HBTL-1098AX] is registered with DRAP under number MDIR-0005877 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-0005877 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00600
| Device | Dialysis Blood tubing line [SHM-HBTL-1098AX] |
|---|---|
| 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 Hospitech Manufacturing services SDN, BHD Sub lot 1, Lot6536, Natu 6, Jalan Bukit Kemuning, 40460 Shah Alam.Selangor Darul Ehsan, Malaysia |
| Issued | 18 Dec 2023 |
| Renewal date | 17 Dec 2028 |
| Licence | ELI-00600 |
Specifications
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Screened 6 Oct 2026, 17:59 (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-0005878 | AV Fistula Needle [2.1mm (14G), 1.8mm (15G), 1.6mm (16G), 1.4mm (17G)] | 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-0008456 | AT-Hemo Blood Tubing Set for Hemodialysis | Class B | Aqib Trading Company (Pvt) Ltd |
| MDIR-0007744 | SMMP Blood Lines for Hemodialysis Machine Sterile | Class B | Mais Medical Products (Pvt) Limited |
| MDMR-000394 | Byonyks APD X1-Cycler Byonyks Bloodless Dialysis Machine [90189030] | Class B | Byonyks Private Limited |
| MDIR-0006467 | OCI (Hemodialysis Blood Tubing Sets) | Class B | MOODY Global Services |
| MDIR-0005625 | Topline (BTL) (Sterile Hemodialysis Blood Circuits, for single use) | Class B | Uniplan Trade International Pvt ltd |
| MDIR-0004991 | Medica Middle East Extracorporeal Blood Line for Hemodialysis for Fresenius Machine | Class B | Medco Line |
| MDIR-0003271 | Hemodialysis Blood Tubing Sets (Blood Tubing Line) [E07023, E07023-TP, E07507] | Class B | Uniplan Trade International Pvt ltd |
| MDIR-0002993 | Rena-Line BTL (Blood Tubing Line for Hemodialysis) | Class C | Renacon Pharma Ltd. |
| MDIR-0002954 | AV-Set-DT-E (Hemodialysis Bloodlines) | Class B | Fresenius Medical Care Pakistan (Pvt) Ltd. |
| MDIR-0002549 | Hemocare Blood Tubing Set for Hemodialysis. [: 20, 20-A, 20-B, 22, 22-A, 22-B, 30, 30-A, 30-B] | Class B | Burraq Enterprises |
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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.