FDA Registration
Active
🇩🇪 Germany
FENTEXMEDICAL GMBH
Reg #: 3006154292
·
FEI: 3006154292
·
Expires 2026
Products
14
Proprietary Names
6
Establishment Types
4
Classifications
14
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Registration Details
- Registration Name
- FENTEXMEDICAL GMBH
- Registration Number
- 3006154292
- FEI Number
- 3006154292
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- TAKE-OFF GEWERBEPARK 2
- City
- NEUHAUSEN, BW Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K032822
Owner / Operator
- Firm Name
- FENTEX MEDICAL GMBH
- Operator Number
- 9093406
- Address
- TAKE-OFF GEWERBEPARK 2, --
- City
- NEUHAUSEN, BW
- State
- DE-NOTA
- Postal Code
- D 78579
- Country
- DE
- Correspondent
- Bert - Sutter
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2006-10-10 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2006-10-10 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2023-12-15 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2006-10-10 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2006-10-10 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2006-10-10 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2006-10-10 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2006-10-10 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2006-10-10 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2006-10-10 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2006-10-10 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2006-10-10 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2006-10-10 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2006-10-10 |
Proprietary Names
MANUAL SURGICAL INSTRUMENT
LIGATURE PASSING AN
MANUAL SURGICAL INSTRUMENTS
MICROSURGICAL EAR PICKS
ENT PROBES
TUNING FORK
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device