FDA Registration
Active
🇩🇰 Denmark
MAJ-1430
Reg #: 3012393058
·
FEI: 3012393058
·
Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BMEDICAL APS
- Registration Number
- 3012393058
- FEI Number
- 3012393058
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- vejlen 31
- City
- Vadum Nordjylland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K131780
Owner / Operator
- Firm Name
- bmedical aps
- Operator Number
- 10083675
- Address
- vejlen 31
- City
- Vadum
- State
- Nordjylland
- Postal Code
- 9430
- Country
- DK
- Correspondent
- mehdi smail
US Agent
- Business Name
- Collaborative medical solutions
- Contact Name
- Trey McIntyre
- Address
- 4134 Birkshire Heights
- City
- Fort Mill
- State
- SC
- ZIP
- 29708
- Country
- US
- [email protected]
- Phone
- 704 4180209
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2022-01-03 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2022-01-03 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2022-01-03 |
Proprietary Names
MAJ-1430
CLV-190
CF-H190I
CV-190
GIF-H190
Establishment Types
Export Device to the United States But Perform No Other Operation on Device