FDA Registration
Active
🇩🇪 Germany
Micromate
Reg #: 3013847349
·
FEI: 3013847349
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- iSYS Medizintechnik GmbH
- Registration Number
- 3013847349
- FEI Number
- 3013847349
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ulrichstrasse 40
- City
- Untermeitingen Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K203720
Owner / Operator
- Firm Name
- ISYS Medizintechnik GmbH
- Operator Number
- 10052093
- Address
- Bergwerksweg 21
- City
- Kitzbuehel
- State
- Salzburg
- Postal Code
- 6370
- Country
- AT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2021-10-25 |
Proprietary Names
Micromate
Establishment Types
Manufacture Medical Device