FDA Registration
Active
🇩🇪 Germany
TROKAMED GMBH
Reg #: 8043746
·
FEI: 3004595684
·
Expires 2026
Products
22
Proprietary Names
28
Establishment Types
2
Classifications
22
Registration Details
- Registration Name
- TROKAMED GMBH
- Registration Number
- 8043746
- FEI Number
- 3004595684
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- KLEINE BREITE 17
- City
- GEISINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K200770
Owner / Operator
- Firm Name
- TROKAMED GMBH
- Operator Number
- 9003550
- Address
- KLEINE BREITE 17, --
- City
- GEISINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78187
- Country
- DE
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 |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2021-09-20 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2006-09-14 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2008-12-22 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2006-04-14 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2008-06-06 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2008-06-06 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2003-01-21 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2008-06-06 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2006-04-14 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2008-02-27 |
| Probe | HXB | Class 1 | Orthopedic | No | 2006-04-07 |
| Trocar, Sinus | KBG | Class 1 | Ear, Nose, Throat | No | 2006-09-14 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2015-04-23 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2006-09-14 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2006-04-14 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2006-09-20 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2008-06-06 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2011-03-11 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2008-06-06 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2008-06-06 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2017-05-17 |
| Trocar, Gastro-Urology | FBQ | Class 2 | Gastroenterology, Urology | No | 2008-06-06 |
Proprietary Names
MULTIPLE HYSTEROSCOPE ACCESSORIES
Puncture Needle
Palpation Probe
MULTIPLE RING APPLICATORS
Optical Biopsy Forceps, Urology
Fan Retractor, Liver Elevator
Frazer suction tube
Puncture and Injection Cannula
MULTIPLE MANUAL SU
Trokamed Fascial Closure ("fsad")
Trokamed Fascial Closure (
11256-004
02-00092
11256-005
Trocar Sleeves and Accessories;
Arthroscope and Accessories;
Cystoscopes and Accessories;
Verres Insufflation Cannula;
Laparoscope and Accessories;
Suction/Irrigation Systems, etc.
LEF10097
ELECTROSURGICAL INSTR
MULTIPLE ACCESSORIES FOR ENDOSCOPE
MULTIPLE FORCEPS
Lowsley Retractors, Straight/Curved
Trocar
Various Manual G-U Instruments
Various Manual Arthroscopic
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)