FDA Registration
Active
🇩🇪 Germany
NH4
Reg #: 3013298536
·
FEI: 3013298536
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Norav Medical GmbH
- Registration Number
- 3013298536
- FEI Number
- 3013298536
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Christof-Ruthof-Weg 10
- City
- Mainz-Kastel Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K111487
Owner / Operator
- Firm Name
- NORAV MEDICAL
- Operator Number
- 9024500
- Address
- 4 HAMADA ST., --
- City
- YOKNEAM
- State
- IL-NOTA
- Postal Code
- 2069202
- Country
- IL
- Correspondent
- YEHUDA - KANNAR
US Agent
- Business Name
- Norav Medical Inc
- Contact Name
- Dennis Dockery
- Address
- 601 N Congress Ave Ste 105
- City
- Delray Beach
- State
- FL
- ZIP
- 33445
- Country
- US
- [email protected]
- Phone
- 561 2744242
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | Class 2 | Cardiovascular | No | 2011-12-14 |
Proprietary Names
NH4
NH4a
NH-301 Ambulatory ECG Analysis Software
NH-301-0
Establishment Types
Manufacture Medical Device