FDA Registration
Active
🇩🇪 Germany
MTT GMBH
Reg #: 3011545155
·
FEI: 3011545155
·
Expires 2026
Products
4
Proprietary Names
16
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- MTT GMBH
- Registration Number
- 3011545155
- FEI Number
- 3011545155
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Boecklerstr. 26
- City
- Lueneburg Lower Saxony
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K122329
Owner / Operator
- Firm Name
- MTT GmbH
- Operator Number
- 10048443
- Address
- Boecklerstr. 26
- City
- Lüneburg
- State
- Lower Saxony
- Postal Code
- 21339
- Country
- DE
- Correspondent
- Stefan Renckly
US Agent
- Business Name
- DK North America LLC
- Contact Name
- Kirby Rust
- Address
- 5588 Benton Woods Dr
- City
- Atlanta
- State
- GA
- ZIP
- 30342
- Country
- US
- [email protected]
- Phone
- 404 9849400
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2021-11-03 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2021-11-03 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2015-01-14 |
| Gastroenterology-Urology Accessories To A Biopsy Instrument | QFZ | Class 1 | Gastroenterology, Urology | No | 2023-03-23 |
Proprietary Names
PeriGrid Reusable
Stepper A-TP
Solidlock Positioning
PeriGrid HDR
Single Use Disposable Template
Stainless Steel Template
Stepper B
PeriGrid Disposable
Probe receptacle (SB) SIUI ECBP (ACCESSORY to Stepper)
SolidLock F
SolidLock HS-500ext
SolidLock HS
Wolf Endomotion System
SolidLock F-500ext
BioJet
TargetPro
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device