Data / Medical devices / Denmark / Natus Medical Denmark ApS
Natus Medical Denmark ApS: FDA-registered device maker in TAASTRUP Hovedstaden, Denmark, 18 510(k) clearances
Natus Medical Denmark ApS is registered with the FDA (registration 9612197) in TAASTRUP Hovedstaden, Denmark. It lists 14 device types. The FDA files 18 510(k) clearances under its listings, the newest dated February 14, 2025. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9612197
- FEI number
- 3002807554
- Address
- Hoerskaetten 9, TAASTRUP Hovedstaden, Denmark, DK-2630
- Owner or operator
- Natus Medical Denmark ApS (10093195)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 10, 2018
- Registered through
- 2027
- Brand names listed
- 011445Flexicoupler and Jellytab Combo Pack, 036177ALGO Pro Newborn Hearing Screening Device, 036234ALGO Pro ATA Cables, 36 inch, 036235ALGO Pro ATA Cables, 72 inch, 036236ALGO Pro PCA Cables, 36 inch, 036237ALGO Pro PCA Cables, 72 inch, 036243ALGO Pro Mobile Cart, 036244ALGO Pro Docking Station and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Vision, Electronic, Battery-Powered | HPG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Apparatus, Vestibular Analysis | LXV | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Audiometer | EWO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Calibrator, Hearing Aid / Earphone And Analysis Systems | ETW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cushion, Earphone (For Audiometric Testing) | ETT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Nystagmograph | GWN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pad, Neonatal Eye | FOK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Caloric-Air | KHH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tester, Auditory Impedance | ETY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Unit, Neonatal Phototherapy | LBI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 14, 2025 | K242198 | ICS Dizcovery (1091) | GWN | Substantially Equivalent | Natus Medical Denmark Aps | accessdata.fda.gov |
| March 8, 2024 | K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | GWJ | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| April 13, 2021 | K203500 | RetCam Envision | HKI | Substantially Equivalent | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | accessdata.fda.gov |
| December 13, 2018 | K182178 | neoBLUE blanket LED Phototherapy System | LBI | Substantially Equivalent | Natus Medical Incorporated | accessdata.fda.gov |
| December 12, 2016 | K160745 | neoBLUE compact LED Phototherapy System | LBI | Substantially Equivalent | Natus Medical Incorporated | accessdata.fda.gov |
| September 1, 2016 | K161707 | Madsen Zodiac | ETY | Substantially Equivalent | Gn Otometrics | accessdata.fda.gov |
| May 27, 2016 | K160305 | neoBLUE® LED Phototherapy System | LBI | Substantially Equivalent | Natus Medical Incorporated | accessdata.fda.gov |
| November 16, 2015 | K151504 | ICS Impulse | GWN | Substantially Equivalent | Gn Otometrics | accessdata.fda.gov |
| August 22, 2014 | K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | GWJ | Substantially Equivalent | Natus Medical Incorporated | accessdata.fda.gov |
| February 27, 2014 | K132957 | MADSEN ACCUSCREEN TYPE 1077 | GWJ | Substantially Equivalent | Gn Otometrics | accessdata.fda.gov |
| February 1, 2013 | K122550 | ICS IMPULSE | GWN | Substantially Equivalent | Gn Otometrics | accessdata.fda.gov |
| October 23, 2012 | K122028 | AURICAL HIT | ETW | Substantially Equivalent | Gn Otometrics | accessdata.fda.gov |
| September 27, 2012 | K122067 | TYPE 1077 ACCUSCREEN | GWJ | Substantially Equivalent | Gn Otometrics | accessdata.fda.gov |
| April 28, 2011 | K110286 | GN OTOMETRICS TYPE 1053 FREEFIT | ETW | Substantially Equivalent | Gn Otometrics A/S | accessdata.fda.gov |
| July 14, 2008 | K081234 | GN OTOMETRICS INSERT EARPHONES | EWO | Substantially Equivalent | Gn Otometrics | accessdata.fda.gov |
| January 25, 2008 | K073665 | ALGO 5 NEWBORN HEARING SCREENER | GWJ | Substantially Equivalent | Natus Medical, Inc. | accessdata.fda.gov |
| March 31, 2004 | K033645 | OTOFLEX 100 TYE 1012 | ETY | Substantially Equivalent | Gn Otometrics A/S | accessdata.fda.gov |
| April 9, 2003 | K030823 | ALGO 3I NEWBORN HEARING SCREENER | GWJ | Substantially Equivalent | Natus Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 1, 2019 | 83491 | Class II | Ongoing | Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. | The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm. | accessdata.fda.gov |
| May 28, 2019 | 83380 | Class II | Terminated | The ICS CHARTR EP 200 | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Neonatal Phototherapy
- All makers of Pad, Neonatal Eye
- All makers of Audiometer
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Aid, Vision, Electronic, Battery-Powered
- All makers of Cushion, Earphone (For Audiometric Testing)
Updated February 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.