FDA Registration
Active
🇩🇰 Denmark
PAUL E. DANCHELL A/S
Reg #: 3008773490
·
FEI: 3008773490
·
Expires 2025
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- PAUL E. DANCHELL A/S
- Registration Number
- 3008773490
- FEI Number
- 3008773490
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lyngvej 8
- City
- Jyderup Sjalland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K130346
Owner / Operator
- Firm Name
- Paul E. Danchell A/S
- Operator Number
- 10042718
- Address
- Lyngvej 8
- City
- Jyderup
- State
- DK-NOTA
- Postal Code
- 4450
- Country
- DK
- Correspondent
- Claus Jensen
US Agent
- Business Name
- Natus
- Contact Name
- Courtney Walton
- Address
- 3610 County Road 101 S
- City
- Wayzata
- State
- MN
- ZIP
- 55391
- Country
- US
- [email protected]
- Phone
- 651 4215870
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2014-12-23 |
| Methyl Methacrylate For Cranioplasty | GXP | Class 2 | Neurology | No | 2014-12-23 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2014-12-23 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2014-12-23 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2014-12-23 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2014-12-23 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2014-12-23 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)