FDA Registration
Active
🇩🇪 Germany
BOWA-ELECTRONIC GMBH & CO. KG
Reg #: 9614969
·
FEI: 1000499348
·
Expires 2026
Products
12
Proprietary Names
29
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- BOWA-ELECTRONIC GMBH & CO. KG
- Registration Number
- 9614969
- FEI Number
- 1000499348
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HEINRICH-HERTZ STRASSE 4-10
- City
- GOMARINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K193591
Owner / Operator
- Firm Name
- BOWA-ELECTRONIC GMBH & CO. KG
- Operator Number
- 9031929
- Address
- HEINRICH-HERTZ STRASSE 4-10, --
- City
- GOMARINGEN
- State
- DE-NOTA
- Postal Code
- 72810
- Country
- DE
US Agent
- Business Name
- EMERGO GLOBAL REPRESENTATION LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Caves Rd Ste 1 Ste 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-09-22 |
| Modular Electromechanical Surgical System | SCV | Class 2 | General, Plastic Surgery | No | 2026-01-07 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2020-07-02 |
| Cable | ISN | Class 1 | Physical Medicine | No | 1997-10-17 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2016-09-22 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2012-12-20 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2016-09-22 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2016-09-22 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2025-08-06 |
| Endoscope, Ac-Powered And Accessories | GCP | Class 2 | Gastroenterology, Urology | No | 2016-09-22 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-09-22 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2016-09-22 |
Proprietary Names
HF-cable
OLYMPUS BIPOLAR FORCEPS
ARC 400
Novapulse
KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION
ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD
Electrosurgery cable
Senhance Surgical System
HF-resection electrodes
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION
HF-RESECTION ELECTRODE ROLLERS AND NEEDLES
LOOPS AND BANDS
Stimuplex Pen
HF cables
BIPOLAR GRASPING FORCEPS BIQ+
BOWA Neutral Electrodes
ROLLER ELECTRODE
UNIPOLAR OPTICAL BIOPSY FORCEPS
HF-cables (reusable)
KSEA BIPOLAR GOAGULATING FORCEPS
HF-cable and Adapter
ENDOSCOPE AND ACCESSORIES
HF-electrodes
OLYMPUS OES LAPAROSCOPY SYSTEM
HI-Q HAND INSTRUMENTS- UROLOGY
KARL STORZ Monopolar Resectoscopes with HF Cable
Autocon III 400
KARL STORZ MONOPOLAR HIGH FREQUENCY CORDS
HI-Q HAND INSTRUMENTS, OB/GYN USE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device