FDA Registration
Active
🇳🇱 Netherlands
UNITRON GROUP BV
Reg #: 3008388260
·
FEI: 3008388260
·
Expires 2026
Products
9
Proprietary Names
14
Establishment Types
1
Classifications
9
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Registration Details
- Registration Name
- UNITRON GROUP BV
- Registration Number
- 3008388260
- FEI Number
- 3008388260
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Schansestraat 7
- City
- IJzendijke Zeeland
- Country
- NL
Owner / Operator
- Firm Name
- Unitron Group BV
- Operator Number
- 10032425
- Address
- Schansestraat 7
- City
- IJzendijke
- State
- Zeeland
- Postal Code
- 4515 RN
- Country
- NL
- Correspondent
- Manon de Koeijer
US Agent
- Business Name
- Qserve Group US Inc
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gutta-Percha | EKM | Class 1 | Dental | No | 2010-05-12 |
| Radiation Therapy Marking Device | QRN | Class 2 | Radiology | No | 2022-03-04 |
| Pillow, Cervical (For Mild Sleep Apnea) | MYB | Class 2 | Dental | No | 2018-11-05 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2010-05-12 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2010-05-12 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2010-05-12 |
| System, Perfusion, Kidney | KDN | Class 2 | Gastroenterology, Urology | No | 2022-01-26 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2026-01-16 |
Proprietary Names
Thermaprep 2 Obturator Oven
GT Obturator Obturator Oven
Thermaprep Plus Obturator Oven
Guttamaster Obturator Oven
GT Series X Obturator Oven
Profile Vortex Obturator Oven
Protaper Universal Obturator Oven
Comfort Marker
Lunoa SPT
Inca
KIDNEY ASSIST-transport
Illumix Retractor Alpha
650100-US Fluido Compact Control Module
650200 Fluido Compact Warming Module
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)