DRAP REGISTERED MEDICAL DEVICE
Bioptimal Thermodilution Catheter & Biotray (Thermodilution Catheter) is registered with DRAP under number MDIR-0005410 as a Class D (high risk) medical device, imported. The listed holder is Alliance Medical. It is listed as valid until 8 Aug 2028.
Screening result
MDIR-0005410 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00147
| Device | Bioptimal Thermodilution Catheter & Biotray (Thermodilution Catheter) |
|---|---|
| Class | D |
| Listed holder | Alliance Medical |
| Holder address | 12-B, 1st Floor, Agro Flats, Shadman, Lahore. |
| Manufacturing site | M/s Bioptimal International Pte. Ltd 36 Jalan Tukang, Singapore 619266 M/s Bioxin Medical Co. Ltd No. 288-7 Shanhai Road, Torch Hi-Tech Science Park, 264209 Weihai, Shandong Province, China |
| Issued | 9 Aug 2023 |
| Renewal date | 8 Aug 2028 |
| Licence | ELI-00147 |
Specifications
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Screened 6 Oct 2026, 00:20 (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-0000243 | ARIES Three Stop Extension Line (Pressure Extension Line) (Extension Line) | Class A |
| MDIE-0000244 | GENOSS Inflator Set (Catheter Balloon) | Class A |
| MDIR-0000223 | Embolectomy Catheter | Class B |
| MDIR-0000224 | Accutarans Pressure Monitoring Systems and Kits | Class B |
| MDIR-0000225 | Central Venous Catheter and Catheterization Kit | Class B |
| MDIR-0000396 | Biosensors Thermodilution Catheter and kit | Class D |
| MDIR-0000397 | Biosensors Bipolar Pacing Catheter | Class D |
| MDIR-0000400 | SELDICATH Arterial Catheter | Class D |
| MDIR-0000401 | OSYPKA TME Temporary Myocardial Electrode (Heart Wire) | Class D |
| MDIR-0000402 | CERABLATE Cool Cardiac Ablation Catheter | Class D |
| MDIR-0000403 | FINDER/Pure Intracardiac Diagnostic Catheter | Class D |
| MDIR-0000404 | VACS Percutaneous Transluminal Valvuloplasty Balloon Catheter | Class D |
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.
