DRAP REGISTERED MEDICAL DEVICE
Dilation Balloon (Precision) is registered with DRAP under number MDIR-0008247 as a Class B (low to moderate risk) medical device, imported. The listed holder is Womas International. It is listed as valid until 21 Mar 2030.
Screening result
MDIR-0008247 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00405
| Device | Dilation Balloon (Precision) |
|---|---|
| Class | B |
| Listed holder | Womas International |
| Holder address | Saadat House, Aqsa Street, Capital Road, Nia Miana Pura, Sialkot |
| Manufacturing site | M/s G-Flex Europe SRL 20, Rue de I ‘Industries 1400-Nivelles Belgium |
| Issued | 22 Mar 2025 |
| Renewal date | 21 Mar 2030 |
| Licence | ELI-00405 |
Specifications
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Screened 6 Oct 2026, 22:06 (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-0003136 | Slider Non-Vascular Guide Wire (Nitinol) [21035150 21435400BS GWO1-25450 GW01-35260 GW01-35450 GW01-35450--S GW02-35300 GW09-001] | Class B |
| MDIR-0003137 | EZY SHOOT Multiband Ligator [GF-OVL100 GF-OVL100-RU GF-OVL300 GF-OVL501 GF-OVL510] | Class B |
| MDIR-0008243 | Sphincterotomes/Papil lotomes (GTome) | Class C |
| MDIR-0008244 | Endoscopic Drainage stents (biliary stents) | Class C |
| MDIR-0008245 | Disposable Hemoclips (SAFECLIP) | Class C |
| MDIR-0008246 | Stone Extraction Balloon Catheter (Stone trigger) | Class B |
| MDIR-0008248 | Disposable Biopsy Forceps (SHARK BITE) | Class B |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0006894 | CRE RX Biliary Balloon Dilatation Catheter Gastrointestinal Dilation Balloon Catheter | Class B | Ferozsons Laboratories Limited |
| MDIR-0006349 | Nc Rockstar Ptca Balloon Dilation Catheter (PTCA Balloon Catheter) | Class B | A & E Medical |
| MDIR-0002733 | NEON PTCA Balloon Dilation Catheter (PTCA balloon Dilation Catheter) | Class D | Global Marketing Services |
| MDIR-0002734 | NEON NC PTCA Balloon Dilation Catheter (PTCA Balloon Dilation Catheter) | Class D | Global Marketing Services |
| MDIR-0001339 | Sprinter OTW (Balloon Dilation Catheter) | Class D | Medtronic Pakistan (Pvt) Ltd. |
| MDIR-0000897 | SIMPASS HP-NC RX BALLOON DILATION CATHETER (PTCA Balloon Dilatation Catheter) | Class D | JK Traders |
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.
