269 Mill Road, Chelmsford, United States, 01824-4105
Showing 1–20 of 848 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| 10K HOUR MAINTENANCE KIT FOR LTV 1150/1200 | 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) |
| 1-STEP PATIENT CABLE FOR 12-LEAD ECG WITH LIMB-LEAD AND V-LEAD CABLES (10 FT) | 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) |
| 1-STEP PATIENT CABLE FOR 12-LEAD ECG WITH LIMB-LEAD AND V-LEAD CABLES (7 FT) | 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) |
| 1X1 AUTO TEST CHARGER | 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) |
| 1 YR LITHIUM BATTERY (FOR USE WITH AED'S) | 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) |
| 30 ECG 1.5" Round Electrodes, 20 Pouches/Case (600) | 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) |
| 30 ECG 1.5" Round Radiotranslucent Electrodes, 10 Pouches/Case (300) | 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) |
| 30 ECG 2" Round Electrodes, 20 Pouches/Case (600) | 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) |
| 30 ECG Rectangular Electrodes, 20 Pouches/Case (600) | 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) |
| 30 ECG Square Electrodes, 20 Pouches/Case (600) | 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) |
| 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator | 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) |
| 3 ECG 2" Round Electrodes, 12 Shelf Cartons/Case (612) | 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) |
| 3 ECG Rectangular Electrodes, 20 Shelf Cartons/Case (600) | 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) |
| 3 Pediatric ECG 1.5" Round Electrodes, 10 Shelf Cartons/Case (300) | 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) |
| 3 YR LITHIUM BATTER (FOR USE WITH AED'S) | 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) |
| 4 ECG Rectangular Electrodes, 10 Shelf Cartons/Case (480) | 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) |
| 4 Pediatric ECG 1.5" Round Electrodes, 10 Shelf Cartons/Case (480) | 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) |
| 4 YR LITHIUM BATTERY (FOR USE WITH AED'S) | 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) |
| 5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES | 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) |
| 5 ECG Rectangular Electrodes, 10 Shelf Cartons/Case (500) | 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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