Pall International SARL
CH-MF-000023177 · Switzerland · Fribourg
Pall International SARL is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 57 |
|---|---|
| Class IIb | 3 |
Most frequent device types declared: 791-02U, AEF1E, BB25, BB25GS, ELD96NTE.
Among these devices, 43 are declared sterile.
Authorised representative in the Union: QbD RepS BV.
Devices declared under this manufacturer
- Gardian™ 25 mm syringe filters, sterile
- PALL Nanodyne ELD filter
- PALL Supor AEF Filter
- PALL insufflator gas line filter
- PALL® PharmAssure 25 mm SYRINGE FILTER WITH LOW PROTEIN BINDING Supor®
- PALL® PharmAssure 32 mm SYRINGE FILTER WITH LOW PROTEIN BINDING Supor®
- PALL® STEM CELL PROCESSING SYSTEM
- PALL® STEM CELL TRANSPLANT SYSTEM
- Pall Breathing System Filter
- Pall Insufflator Gas Line Filter
- Pall Supor™ AEF Filter
- Pall Ultipor 100 Breathing system Filter
Showing 12 of 60 declared devices.
Catalogue references include 6094184, 791-02U, 791-03U, BB25DFG, BB25FG, BB25FU.
European nomenclature codes declared: R040102, A04010101, A0499, R040101, B0105, Z12029085.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Pall International, Sarl (CH) · FDA 3008412416 |
| Devices in EUDAMED | 60 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 60 |
|---|---|
| Found in the U.S. device database | 17 |
| Share | 28.3 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Pall International SARL is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ECM24MDR007 | supplemented | 2029-09-08 |