FDA Registration
Active
🇩🇪 Germany
FIOR AND GENTZ GMBH
Reg #: 3011404939
·
FEI: 3011404939
·
Expires 2026
Products
5
Proprietary Names
69
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- FIOR AND GENTZ GMBH
- Registration Number
- 3011404939
- FEI Number
- 3011404939
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Dorette-von-Stern-Strasse 5
- City
- Lueneburg Lower Saxony
- Country
- DE
Owner / Operator
- Firm Name
- Fior & Gentz Gesellschaft fuer Entwicklung und Vertrieb von
- Operator Number
- 10050337
- Address
- Dorette-von-Stern-Strasse 5
- City
- Lüneburg
- State
- Lower Saxony
- Postal Code
- 21337
- Country
- DE
- Correspondent
- Thomas Gast
US Agent
- Business Name
- Ossur
- Contact Name
- Katla Axelsdottir
- Address
- 200 Spectrum Center Dr Ste 700
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3823833
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2024-08-29 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2015-11-05 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2023-07-25 |
| Shoe With Adjustable Sole Units | QDT | Class 1 | Physical Medicine | No | 2024-08-29 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2023-07-25 |
Proprietary Names
Madrid
Frankfurt
Erfurt Standard
Hamburg
Stendal
Kopenhagen
Augsburg Breit
Flensburg Standard
Mailand
Stuttgart
Erfurt Breit
Amsterdam
Wetzlar
Kassel Breit
Muenchen
Wuppertal
Nuernberg Breit
Augsburg Standard
London
Bremen
Nuernberg Standard
Stockholm
Heidelberg
Dresden Breit
Leipzig
Hannover
Kassel Standard
Freiburg
Koeln
Konstanz
Berlin
Dresden Standard
Regensburg
NEURO SWING FIT AFO
Service Fabrication AFO/KAFO
NEURO HiTRONIC
NEURO LOCK
NEURO CLASSIC zero
NEURO CLASSIC
NEURO FLEX MAX (step lock function)
NEURO LOCK MAX
NEURO CLASSIC Carbon
NEURO VARIO-SWING
NEURO MATIC
NEURO VARIO zero
NEURO VARIO 2
NEURO VARIO
NEURO ACTIVE (system side bar)
NEURO ACTIVE (system joint)
NEURO TRONIC
NEURO LOCK Carbon
NEURO FLEX MAX (lock function)
CROSSROADS schwarz
CITYDRIVE
PARKSTREET
URBANSTREET
CROSSROADS braun
NEURO HiSWING
NEURO SWING 2
NEURO SWING Carbon
NEURO VARIO-CLASSIC
NEURO SWING-CLASSIC
NEURO CLASSIC-SPRING
NEURO VARIO-SPRING
NEURO SWING
NEURO CLASSIC-SWING
NEURO VARIO-SPRING 2
NEURO HiSWING R+
NEURO VARIO-CLASSIC 2
Establishment Types
Manufacture Medical Device