Natus Medical Denmark ApS
DK-MF-000001617 · Denmark · Taastrup
Natus Medical Denmark ApS is registered in the European database on medical devices as a manufacturer, with 358 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 358 |
|---|
Most frequent device types declared: 011010, 1081 Aurical Aud, 1085 ICS Impulse System, 8-04-16030, 8-68-31514.
Among these devices, 1 are declared sterile, 7 reusable, 286 active, 75 with a measuring function.
Devices declared under this manufacturer
- 1066 MADSEN Astera 2
- 1081 Madsen A450
- 1085 Face Cushion (10 Boxes/120 Cushions)
- 1085 ICS Impulse Incl. Lateral Head Impulse
- 1085 ICS Impulse Monocular Ocu. Ltd.,Lateral Head Imp,LARP/RALPHead Im
- 1096 Madsen Zodiac
- 1096 Zodiac PC Diagnostic, Incl. Comfort Probe
- AURICAL AUD
- ICS Impulse Lateral, LARP/RALP, DSral, LARP/RALP, DS
- Madsen AccuScreen
- Madsen Accuscreen
- Madsen Zodiac
Showing 12 of 358 declared devices.
Catalogue references include 8-04-13936, 8-04-14550, 8-04-14668, 8-04-16322, 8-04-16334, 8-04-16339.
European nomenclature codes declared: Z121401, Z129013, Z12149005, Z12120124, Y214599, Z12080401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Natus Medical Denmark ApS (DK) · FDA 9612197 |
| Devices in EUDAMED | 358 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 358 |
|---|---|
| Found in the U.S. device database | 174 |
| Share | 48.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NATUS MEDICAL DENMARK APS |
What it holds in Canada
| Licences on record | 28 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 26 |
| Class 3 devices | 2 |
| First licensed | 1999-06-11 |
Licence types: System (10), Single Device (8), Device Family (7), Device Group Family (2).
Licensed under: BILI-METER, ALGO JELLY TAB SENSORS, ALGO FLEXICOUPLER DISPOSABLE EARPHONES, AUDIOMETERS, HI PROGRAMMERS, ALGO 3I NEWBORN HEARING SCREENER.
North American profile: Both markets. Natus Medical Denmark ApS is registered in both the United States and Canada.