FDA Registration
Active
🇩🇰 Denmark
041554ALGO Pro Bassinet Hook
Reg #: 9612197
·
FEI: 3002807554
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Natus Medical Denmark ApS
- Registration Number
- 9612197
- FEI Number
- 3002807554
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hoerskaetten 9
- City
- TAASTRUP Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K233649
Owner / Operator
- Firm Name
- Natus Medical Denmark ApS
- Operator Number
- 10093195
- Address
- 2630 TAASTRUP, Hoerskaetten 9
- City
- Copenhagen
- State
- DK-NOTA
- Postal Code
- 2630
- Country
- DK
- Correspondent
- Martha Kennedy
US Agent
- Business Name
- Natus Sensory Inc
- Contact Name
- Danda Zhao
- Address
- 50 Commerce Drive, Suite 180, Schaumburg
- City
- Schaumburg
- State
- IL
- ZIP
- 60173
- Country
- US
- [email protected]
- Phone
- 224 2548140
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2025-05-13 |
Proprietary Names
041554ALGO Pro Bassinet Hook
040587Jelly Tab Electrodes
036244ALGO Pro Docking Station
011445Flexicoupler and Jellytab Combo Pack
036237ALGO Pro PCA Cables, 72 inch
042055ALGO Pro DC-DC converter module
040670Valu-Pack
036236ALGO Pro PCA Cables, 36 inch
036235ALGO Pro ATA Cables, 72 inch
036177ALGO Pro Newborn Hearing Screening Device
036243ALGO Pro Mobile Cart
036234ALGO Pro ATA Cables, 36 inch
040546ALGO-Pack
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device