FDA Registration
Active
🇩🇰 Denmark
Ambu WhiteSensor
Reg #: 9610691
·
FEI: 3002806359
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Ambu A/S
- Registration Number
- 9610691
- FEI Number
- 3002806359
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Baltorpbakken 13
- City
- Ballerup Hovedstaden
- Country
- DK
Owner / Operator
- Firm Name
- AMBU A/S
- Operator Number
- 8010067
- Address
- 13 BALTORPBAKKEN, --
- City
- BALLERUP
- State
- DK-NOTA
- Postal Code
- DK-2750
- Country
- DK
US Agent
- Business Name
- Ambu Inc
- Contact Name
- Sanjay Parikh
- Address
- 6721 Columbia Gateway Drive, Suite 200
- City
- Columbia
- State
- MD
- ZIP
- 21046
- Country
- US
- [email protected]
- Phone
- 410 7686464 ext. 1136
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2013-05-06 |
Proprietary Names
Ambu WhiteSensor
Ambu BlueSensor 2300
ECG Electrodes
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Develop Specifications But Do Not Manufacture At This Facility