FDA Registration
Active
🇸🇪 Sweden
Mandometer
Reg #: 3009128345
·
FEI: 3009128345
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AB MANDO
- Registration Number
- 3009128345
- FEI Number
- 3009128345
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Halsovagen 7
- City
- HUDDINGE Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- DEN070014
Owner / Operator
- Firm Name
- AB Mando
- Operator Number
- 10036109
- Address
- Halsovagen 7
- City
- HUDDINGE
- State
- Stockholm
- Postal Code
- S-141 04
- Country
- SE
- Correspondent
- Cecilia Bergh
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Eating Disorder Conditioning Tool | OBV | Class 2 | Neurology | No | 2011-04-20 |
Proprietary Names
Mandometer
Establishment Types
Manufacture Medical Device