FDA Registration
Active
🇬🇧 United Kingdom
TEMED Gas Diffuser
Reg #: 3014247825
·
FEI: 3014247825
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- TEMED
- Registration Number
- 3014247825
- FEI Number
- 3014247825
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 3 Keynor Farm, Keynor Lane
- City
- Sidlesham West Sussex
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K173545
Owner / Operator
- Firm Name
- TEMED
- Operator Number
- 10057063
- Address
- Unit 3, Keynor Farm, Keynor Lane
- City
- Sidlesham
- State
- West Sussex
- Postal Code
- PO20 7LL
- Country
- GB
- Correspondent
- Katie Evans
US Agent
- Business Name
- Med Alliance Group INC
- Contact Name
- Mike Schroeder
- Address
- 2175 Oakland Drive
- City
- Sycamore
- State
- IL
- ZIP
- 60178
- Country
- US
- [email protected]
- Phone
- 630 4437070 ext. 101
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2018-02-16 |
Proprietary Names
TEMED Gas Diffuser
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device