FDA Registration
Active
🇩🇪 Germany
DOT GMBH
Reg #: 3006001176
·
FEI: 3006001176
·
Expires 2026
Products
19
Proprietary Names
3
Establishment Types
1
Classifications
19
Registration Details
- Registration Name
- DOT GMBH
- Registration Number
- 3006001176
- FEI Number
- 3006001176
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Charles-Darwin-Ring 1a
- City
- Rostock Mecklenburg-Western Pomerania
- Country
- DE
Owner / Operator
- Firm Name
- DOT GmbH
- Operator Number
- 10037690
- Address
- Charles-Darwin-Ring 1a
- City
- Rostock
- State
- Mecklenburg-Western Pomerania
- Postal Code
- 18059
- Country
- DE
- Correspondent
- Katrin Wenke
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 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 |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-11-26 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2025-12-12 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2025-12-12 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2014-03-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-01-16 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-01-18 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2021-03-26 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2013-01-18 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2020-08-12 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-08-12 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2026-03-27 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-01-18 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2013-01-18 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2024-11-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2011-08-08 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2011-08-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-21 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2013-01-18 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2015-01-16 |
Proprietary Names
EcoFit® short stem cementless
EXODUS HIP STEM REMOVAL BLADES
Z1 Hip Stem
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)