FDA Registration
Active
🇩🇰 Denmark
PAUL E. DANCHELL A/S
Reg #: 3008773490
·
FEI: 3008773490
·
Expires 2026
Products
15
Proprietary Names
4
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- PAUL E. DANCHELL A/S
- Registration Number
- 3008773490
- FEI Number
- 3008773490
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lyngvej 8
- City
- Jyderup Sjalland
- Country
- DK
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
- Global Compliance Plus
- Contact Name
- Travis Garth
- Address
- 325 Big Elm St
- City
- Highland Village
- State
- TX
- ZIP
- 75077
- Country
- US
- [email protected]
- Phone
- 469 9394909
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 |
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2015-01-15 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2024-12-11 |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | Class 2 | Hematology | No | 2024-12-11 |
| Stimulator, Mechanical, Evoked Response | GZP | Class 2 | Neurology | No | 2025-01-29 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2026-02-24 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2012-12-20 |
| Amplifier, Physiological Signal | GWL | Class 2 | Neurology | No | 2012-12-20 |
| Coronary Artery Disease Risk Indicator From Acoustic Heart Signals | QMW | Class 2 | Cardiovascular | No | 2024-12-11 |
Proprietary Names
°M Warmer System
Ultrapro S100
3CP Centrifuge
CADScor System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)