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
Phone
224 2548140

Products

Device Name Product Code
Cushion, Earphone (For Audiometric Testing) ETT

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