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
Phone
224 2548140

Products

Device Name Product Code
Stimulator, Auditory, Evoked Response GWJ

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