FDA Registration
Active
🇩🇪 Germany
GIMMI GMBH
Reg #: 9612074
·
FEI: 3002807072
·
Expires 2025
Products
23
Proprietary Names
0
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- GIMMI GMBH
- Registration Number
- 9612074
- FEI Number
- 3002807072
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CARL-ZEISS-STRASSE 6
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K012660
Owner / Operator
- Firm Name
- GIMMI GMBH
- Operator Number
- 8010570
- Address
- CARL-ZEISS-STRASSE 6, --
- City
- TUTTLINGEN
- State
- DE-NOTA
- Postal Code
- D-78532
- Country
- DE
- Correspondent
- Dr. Matthias Schmidt
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-11-27 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2007-11-27 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Dislodger, Stone, Biliary | LQR | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Catheter, Cholangiography | GBZ | Class 1 | General, Plastic Surgery | No | 2007-11-27 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Urethroscope | FGC | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2007-11-27 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2007-11-27 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2007-11-27 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2007-11-27 |
Establishment Types
Manufacture Medical Device