DRAP REGISTERED MEDICAL DEVICE
ACROSS HP (PTCA Balloon Catheter) Sterile [Sizes: 1.5-10, 1.5-15, 1.5-20, 2.0-10, 2.0-15, 2.0-20, 2.5-10, 2.5-10, 2.5-15, 2.5-20, 3.0-10, 3.0-10, 3.0-15, 3.0-20, 3.5-10, 3.5-10, 3.5-15, 3.5-20, 4.0-10, 4.0-15, 4.0-20, 4.5-10, 4.5-15,4.5-20] is registered with DRAP under number MDIR-0003377 as a Class D (high risk) medical device, imported. The listed holder is Medi Systems International. It is listed as valid until 13 May 2027.
Screening result
MDIR-0003377
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00696
| Device | ACROSS HP (PTCA Balloon Catheter) Sterile [Sizes: 1.5-10, 1.5-15, 1.5-20, 2.0-10, 2.0-15, 2.0-20, 2.5-10, 2.5-10, 2.5-15, 2.5-20, 3.0-10, 3.0-10, 3.0-15, 3.0-20, 3.5-10, 3.5-10, 3.5-15, 3.5-20, 4.0-10, 4.0-15, 4.0-20, 4.5-10, 4.5-15,4.5-20] |
|---|---|
| Class | D |
| Listed holder | Medi Systems International |
| Holder address | 5-A Mezzanine Floor, Sardar Begum Plaza, 109 west blue area, Islamabad |
| Manufacturing site | M/s Acrostak (Schweiz) AG Stegackerstrasse, 8409 Winterthur, Switzerland |
| Issued | 14 May 2022 |
| Renewal date | 13 May 2027 |
| Licence | ELI-00696 |
Specifications
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Screened 5 Oct 2026, 11:40 (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-0003378 | ACROSS CTO RX (PTCA Balloon Catheter) Sterile [ Sizes: 1.1-1 , 1.1-15, 1.1-20, 1.5-10, 1.5-15, 1.5-20,… | Class D |
| MDIR-0003379 | GRIPTT (PTCA Balloon Catheter) [2.5-8, 2.5-12, 2.5-16, 3.0-8, 3.0-12, 3.0-16, 3.5-8, 3.5-12, 3.5-16, 4.0-8, 4.0-12, 4.0-16] | Class D |
| MDIR-0003754 | M-CATH (Microcatheter) [750135730] | Class D |
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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.