Natus Manufacturing Limited
IE-MF-000000799 · Ireland · Gort, Co Galway
Natus Manufacturing Limited is registered in the European database on medical devices as a manufacturer, with 171 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 171 |
|---|
Most frequent device types declared: MRSIN1-39;MRSIN2-39;MRSIN3-39;MRSIN1-59;MRSIN2-59;MRSIN3-59;MRARR27-59.
Among these devices, 39 are declared sterile, 59 active.
Devices declared under this manufacturer
- Control Panel, Keypoint G4
- Dantec Clavis
- Dantec® DCN Disposable Concentric Needle Electrodes, 1.5” (37mm) lengt
- Dantec® DCN Disposable Concentric Needle Electrodes, 1” (25mm) length,
- Disposable Injectable MyoJect Red Luer Lock NEEDLE 25mm LG x 0.32mm, 1
- Genuine Grass® Gold Disc Electrodes - Reusable
- Genuine Grass® Silver Disc Electrodes - Reusable
- Grass® MR Conditional/CT Array Cup Electrodes
- Holder for Dantec DCN Disposable Concentric Needle Electrode
- Keypoint Focus Workstation, DEU
- Natus EMG Cables
- Natus Keypoint G4 Desktop System, ENG, 230V
Showing 12 of 171 declared devices.
Catalogue references include 9013C0014, 9015A0012, 902-DMF37-S, 9031A07D-EN230, 9031G0711, F-E5SH-72.
European nomenclature codes declared: N010101, N010199, Z12100485, Z12100480, Z120622,Z12100401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Natus Manufacturing Limited (IE) · FDA 3005581270 |
| Devices in EUDAMED | 171 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 171 |
|---|---|
| Found in the U.S. device database | 115 |
| Share | 67.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NATUS MANUFACTURING LIMITED |
What it holds in Canada
| Licences on record | 13 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| First licensed | 1999-02-16 |
Licence types: Device Family (8), Single Device (3), System (1), Device Group Family (1).
Licensed under: KEYPOINT SYSTEM, TECA DISPOSABLE MYOJECT NEEDLE, TECA DISPOSABLE CONCENTRIC NEEDLE ELECTRODES, TECA DISPOSABLE MONOPOLAR NEEDLE, CLAVIS, ELECTRODES.
North American profile: Both markets. Natus Manufacturing Limited is registered in both the United States and Canada.