FDA Registration
Active
🇩🇪 Germany
Ermis MedTech
Reg #: 3005071827
·
FEI: 3005071827
·
Expires 2026
Products
11
Proprietary Names
0
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- Ermis MedTech
- Registration Number
- 3005071827
- FEI Number
- 3005071827
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- DORNIERSTRASSE 49
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K123234
Owner / Operator
- Firm Name
- Ermis MedTech GmbH
- Operator Number
- 9071497
- Address
- DORNIERSTRASSE 49, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- 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 |
|---|---|---|---|---|---|
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2005-03-18 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2005-03-18 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2005-03-18 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2010-11-30 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2013-07-15 |
| Probe | HXB | Class 1 | Orthopedic | No | 2010-11-30 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2005-03-18 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2010-05-07 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2010-11-30 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2010-05-07 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2010-11-30 |
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device