FDA Registration
Active
🇬🇧 United Kingdom
GoSpiro
Reg #: 3014128536
·
FEI: 3014128536
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDCHIP SOLUTIONS LIMITED
- Registration Number
- 3014128536
- FEI Number
- 3014128536
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- (Beak Kemmence), 1-3 Manor Road
- City
- Chatham Kent
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K202837
Owner / Operator
- Firm Name
- MedChip Solutions Limited
- Operator Number
- 10078506
- Address
- (Beak Kemmence), 1-3 Manor Road
- City
- Chatham
- State
- Kent
- Postal Code
- ME4 6AE
- Country
- GB
- Correspondent
- Barry Sugarman
US Agent
- Business Name
- Monitored Therapeutics, Inc.
- Contact Name
- Barry Sugarman
- Address
- 1730 Michael Lane
- City
- Pacific Palisades
- State
- CA
- ZIP
- 90272
- Country
- US
- [email protected]
- Phone
- 310 4131658
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2021-01-09 |
Proprietary Names
GoSpiro
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)