FDA Registration
Active
🇩🇰 Denmark
OAE Preemie TreeTip (20)
Reg #: 9612197
·
FEI: 3002807554
·
Expires 2025
Products
1
Proprietary Names
27
Establishment Types
2
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
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 |
|---|---|---|---|---|---|
| Cushion, Earphone (For Audiometric Testing) | ETT | Class 1 | Ear, Nose, Throat | No | 2025-05-13 |
Proprietary Names
OAE Preemie TreeTip (20)
Silicone Eartip, 12.5 mm, semi red, mushroom (50 pcs)
Silicone Eartip, 22 mm, transparent, umbrella (50 pcs)
Silicone Eartip, 9.5 mm, semi blue, mushroom (50 pcs)
Silicone Eartip, 19 mm, transparent, umbrella (50 pcs)
Silicone Eartip, 7 mm, semi red, mushroom (50 pcs)
Silicone Eartip, 18 mm, semi gray, mushroom (50 pcs)
Silicone Eartip, 16 mm, transparent, umbrella (50 pcs)
Foam Eartip 3A Standard
Silicone Eartip, 14 mm, semi green, mushroom (50 pcs)
Silicone Eartip, 6 mm, semi gray, mushroom (50 pcs)
OAE Adult Foam Tip (20)
OAE TreeTip (20)
OAE Jumbo Foam Tip (100)
OAE Adult Foam Tip (100)
OAE Preemie TreeTip (100)
OAE Pediatric Foam Tip (100)
OAE TreeTip (100)
Silicone Eartip, 16 mm, semi blue, mushroom (50 pcs)
Silicone Eartip, 10 mm, transparent, umbrella (50 pcs)
Silicone Eartip, 5 mm, blue, tree tip (50 pcs)
Silicone Eartip, 13 mm, transparent, umbrella (50 pcs)
Foam Eartip 3C Jumbo
OAE Pediatric Foam Tip (20)
Silicone Eartip, 8 mm, semi green, mushroom (50 pcs)
Silicone Eartip, 11 mm, semi gray, mushroom (50 pcs)
Foam Eartip 3B Small
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility