FDA Registration
Active
🇩🇪 Germany
CCS-200 Spirometer
Reg #: 3002504821
·
FEI: 3002504821
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- MAICO Diagnostics GmbH
- Registration Number
- 3002504821
- FEI Number
- 3002504821
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Sickingenstr. 70-71
- City
- Berlin
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K123896
Owner / Operator
- Firm Name
- DEMANT A/S
- Operator Number
- 8010048
- Address
- KONGEBAKKEN 9, --
- City
- SMORUM
- State
- DK-NOTA
- Postal Code
- DK-2765
- Country
- DK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2020-09-25 |
Proprietary Names
CCS-200 Spirometer
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198