FDA Registration
Active
🇩🇪 Germany
SMI MEDICAL INSTRUMENTS GMBH & CO.KG
Reg #: 8010871
·
FEI: 6166
·
Expires 2026
Products
24
Proprietary Names
2
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- SMI MEDICAL INSTRUMENTS GMBH & CO.KG
- Registration Number
- 8010871
- FEI Number
- 6166
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Robert Bosch Strasse 36
- City
- NEUHAUSEN OB ECK Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K945474
Owner / Operator
- Firm Name
- SMI MEDICAL INSTRUMENTS GMBH & CO KG
- Operator Number
- 8010871
- Address
- ROBERT-BOSCH-STRASSE 36, --
- City
- NEUHAUSEN OB ECK
- State
- DE-NOTA
- Postal Code
- D-78579
- Country
- DE
- Correspondent
- FLORIAN - STRITZEL
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 |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-01-14 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1988-02-08 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1988-02-08 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1988-02-08 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2022-11-14 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2004-05-12 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-07-23 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2014-05-14 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2004-05-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2014-11-26 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2022-11-14 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1988-02-08 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2013-01-10 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1988-02-08 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1988-02-08 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2004-05-12 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2013-01-14 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1988-02-08 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1988-02-08 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1988-02-08 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1988-08-17 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1988-08-17 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2021-01-14 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1988-02-08 |
Proprietary Names
3795-01BP
80100081
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)