FDA Registration
Active
🇩🇪 Germany
Vitalitec International Medizintechnik GmbH
Reg #: 8044057
·
FEI: 3003445992
·
Expires 2026
Products
18
Proprietary Names
20
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- Vitalitec International Medizintechnik GmbH
- Registration Number
- 8044057
- FEI Number
- 3003445992
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- STEIGAECKER 20
- City
- BALGHEIM Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K942730
Owner / Operator
- Firm Name
- VITALITEC INTERNATIONAL MEDIZINTECHNIK GMBH
- Operator Number
- 9005335
- Address
- Steigaecker 20, --
- City
- BALGHEIM
- State
- Baden-Wurttemberg
- Postal Code
- D-78582
- Country
- DE
US Agent
- Business Name
- Business Support International
- Contact Name
- Angelika Scherp
- Address
- 1350 Avenue Of The Americas Fl 2
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 212 3318358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2017-07-15 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2017-07-14 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2017-04-01 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2017-07-18 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2017-07-15 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2009-03-19 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2017-07-15 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2017-07-15 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 1992-06-04 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2017-07-15 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2017-04-01 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1992-06-04 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1992-06-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-03-27 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2010-05-11 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2009-09-21 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2009-09-21 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 1992-06-04 |
Proprietary Names
Enlarging Bur
Hudson brace, handle only
Aesculap
Forceps
Grasping and Dissecting Forceps, Scissors, endoscopy
Forceps, Biopsy, Gynecological
Laparoscopic Instruments, monopolar
Suction Tip
Wire Saw
INSTRUMENTS FOR LIGATURE
Elevator
Arthroscopic sheaths/trocars
Needle Holder
Dissecting scissors
Suction Irrigation devices, trocar sheaths, ports and accessories
Veress Insufflation Cannula
Suction Irrigation Systems, Trocars
Sleeves and Accessories;
Rongeur Surgical Forceps
Gynecology Biopsy Punches and Forceps
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility