Data / Medical devices / United Kingdom / Europlaz Technologies Ltd.
Europlaz Technologies Ltd.: FDA-registered device maker in Southminster Essex, United Kingdom, 1 510(k) clearance
Europlaz Technologies Ltd. is registered with the FDA (registration 3004180226) in Southminster Essex, United Kingdom. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004180226
- FEI number
- 3001598088
- Address
- The Maltings Industrial Estate, Southminster Essex, United Kingdom, CM07EQ
- Owner or operator
- Europlaz Technologies Ltd. (10042366)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 24, 2013
- Registered through
- 2026
- Brand names listed
- BVI Visitec® Manipulators, Beaver Visitec Internatlional Scleral Marker, C-STEM, EndoSign® Cell collection device, Endocuff Vision, Quadsense
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Contract manufacturer | accessdata.fda.gov |
| Esophagoscope (Flexible Or Rigid) | EOX | 2 | Contract manufacturer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Contract manufacturer | accessdata.fda.gov |
| Intraoperative Orthopedic Joint Assessment Aid | ONN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Marker, Sclera | HMQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Oral Administration Set | PXA | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | 2 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 4, 2024 | K241298 | QUADSENSE | ONN | Substantially Equivalent | Eventum Orthopaedics, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Marker, Sclera
- All makers of Esophagoscope (Flexible Or Rigid)
- All makers of Forceps, Ophthalmic
Updated October 4, 2024. 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.