FDA Registration
Active
🇩🇪 Germany
INKUTEC GMBH
Reg #: 3006846433
·
FEI: 3006846433
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- INKUTEC GMBH
- Registration Number
- 3006846433
- FEI Number
- 3006846433
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hanskampring 8
- City
- Barsbüttel Schleswig-Holstein
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K102992
Owner / Operator
- Firm Name
- INKUTEC GmbH
- Operator Number
- 10043838
- Address
- Hanskampring 8
- City
- Barsbüttel
- State
- Schleswig-Holstein
- Postal Code
- 22885
- Country
- DE
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 |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-03-27 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2022-08-18 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-03-27 |
Proprietary Names
STERILIZATION TRAY DRAPELINK CRANIAL
Steritray
OLYMPUS STERILIZATION TRAYS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device