FDA Registration
Active
🇩🇪 Germany
Contract Medical International GmbH
Reg #: 3003637635
·
FEI: 3003637635
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Contract Medical International GmbH
- Registration Number
- 3003637635
- FEI Number
- 3003637635
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lauensteiner Strasse 37
- City
- DRESDEN Saxony
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K181463
Owner / Operator
- Firm Name
- CONTRACT MEDICAL INTL. GMBH
- Operator Number
- 9049562
- Address
- Lauensteiner Strasse 37
- City
- DRESDEN
- State
- DE-NOTA
- Postal Code
- 01277
- Country
- DE
- Correspondent
- Klara - Safrankova
US Agent
- Business Name
- Heraeus Medical Components, LLC
- Contact Name
- Timothy Desaulniers
- Address
- 5030 Centerville Rd
- City
- Saint Paul
- State
- MN
- ZIP
- 55127
- Country
- US
- [email protected]
- Phone
- 612 3252003
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Percutaneous Retrieval | MMX | Class 2 | Cardiovascular | No | 2023-03-14 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2018-12-19 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2018-12-19 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2023-03-14 |
| Stent Graft, Infrapopliteal, Venous Arterialization | QWN | Class 3 | Unknown | No | 2023-10-25 |
| Valvulotome | MGZ | Class 2 | Cardiovascular | No | 2023-03-14 |
Proprietary Names
LimFlow V-Ceiver
DuraSheath Introducer Sheath System
Compass Guiding Introducer Sheath
LimFlow ARC
Fortress
Guide Sheath
Hemostasis Valve
LimFlow System
LimFlow Vector
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device