Data / Medical devices / United Kingdom / Temed
Temed: FDA-registered device maker in Sidlesham West Sussex, United Kingdom, 1 510(k) clearance
Temed is registered with the FDA (registration 3014247825) in Sidlesham West Sussex, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 14, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014247825
- Address
- Unit 3 Keynor Farm Keynor Lane, Sidlesham West Sussex, United Kingdom, PO20 7LL
- Owner or operator
- TEMED (10057063)
- Roles
- Exporter to the US, Specification developer
- First device listed
- February 16, 2018
- Registered through
- 2026
- Brand names listed
- TEMED Gas Diffuser, TEMED Mini Sucker, TEMED Sucker Line
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 14, 2018 | K173545 | TEMED Gas Diffuser | HIF | Substantially Equivalent | Temed | accessdata.fda.gov |
Compare with other makers
- All makers of Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- All makers of Insufflator, Laparoscopic
Updated February 14, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.