DRAP REGISTERED MEDICAL DEVICE
ORBERA365 Intragastric Balloon System [B-50012 ] is registered with DRAP under number MDIR-0006219 as a Class C (moderate to high risk) medical device, imported. The listed holder is Ferozsons Laboratories Limited. It is listed as valid until 30 Jan 2029.
Screening result
MDIR-0006219
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00120
| Device | ORBERA365 Intragastric Balloon System [B-50012 ] |
|---|---|
| Class | C |
| Listed holder | Ferozsons Laboratories Limited |
| Holder address | Godown: Amangarh, Nowshera-KPK, Pakistan |
| Manufacturing site | M/s Apollo Endosurgery, Inc., 1120 South Capital of Texas Highway, Building 1, Suite 300, Austin, Texas 78746 USA M/s Apollo Endosurgery, Costa Rica S.R.L Building B 13.3, zona franca Coyol, Alajuela, Costa Rica 20113 |
| Issued | 31 Jan 2024 |
| Renewal date | 30 Jan 2029 |
| Licence | ELI-00120 |
Specifications
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Screened 5 Oct 2026, 12:04 (Pakistan time). A screening aid, not an official DRAP verification.
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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.