33 Technology Drive, Irvine, United States, 92618
Showing 1–20 of 137 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| 0.55% ORTH-PHTHALALDEHYDE SOLUTION | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| AEROFLEX AUTOMATIC ENDOSCOPE REPROCESSOR | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ALLCLEAR TECHNOLOGY SOFTWARE UPGRADE FOR STERRAD 100NX SYSTEM | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ALLCLEAR TECHNOLOGY SOFTWARE UPGRADE FOR STERRAD NX SYSTEM | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 180 mm x 75 mm x 30 mm (7 in x 3 in x 1.2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 250 mm x 150 mm x 30 mm (10 in x 6 in x 1.2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 278 mm x 270 mm x 100 mm (11 in x 10-5/8 in x 4 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 300 mm x 100 mm x 50 mm (12 in x 4 in x 2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 300 mm x 200 mm x 50 mm (12 in x 8 in x 2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 380 mm x 150 mm x 30 mm (15 in x 6 in x 1.2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 380 mm x 250 mm x 30 mm (15 in x 10 in x 1.2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 450 mm x 100 mm x 50 mm (18 in x 4 in x 2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 450 mm x 200 mm x 50 mm (18 in x 8 in x 2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 570 mm x 270 mm x 100 mm (22-7/16 in x 10-5/8 in x 4 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 596 mm x 321 mm x 100 mm (23-15/32 in x 12-21/32 in x 4 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 600 mm x 100 mm x 50 mm (24 in x 4 in x 2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Aptimax™ Instrument Tray 600 mm x 200 mm x 50 mm (24 in x 8 in x 2 in) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| APTIMAX™ Instrument Tray for ULTRA GI™ Cycle | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| APTIMAX™ Instrument Trays | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
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