FDA Registration
Active
🇩🇪 Germany
MNA-110 ENC DP
Reg #: 9610773
·
FEI: 3002807798
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OLYMPUS WINTER & IBE GMBH
- Registration Number
- 9610773
- FEI Number
- 3002807798
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KUEHNSTRASSE 61
- City
- HAMBURG
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K122167
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
US Agent
- Business Name
- Gyrus ACMI, Inc.
- Contact Name
- Todd Brill
- Address
- 800 West Park Drive, --
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2023-11-15 |
Proprietary Names
MNA-110 ENC DP
MNA-120 ENC DVI AUDIO
MNA-110 ENC DVI
MNA-120 ENC DP AUDIO
MNA-120 DEC DVI AUDIO
MNT-120 H.264
MNA-120 ENC HDSDI AUDIO
MNA-240 Ouad Decoder
MNA-110 ENC HDSDI
Establishment Types
Export Device to the United States But Perform No Other Operation on Device