FDA Registration
Active
🇬🇧 United Kingdom
EUROPLAZ TECHNOLOGIES LTD.
Reg #: 3004180226
·
FEI: 3001598088
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- EUROPLAZ TECHNOLOGIES LTD.
- Registration Number
- 3004180226
- FEI Number
- 3001598088
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- The Maltings Industrial Estate
- City
- Southminster Essex
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K241298
Owner / Operator
- Firm Name
- Europlaz Technologies Ltd.
- Operator Number
- 10042366
- Address
- The Maltings Industrial Estate
- City
- Southminster
- State
- Essex
- Postal Code
- CM07EQ
- Country
- GB
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- HAMPTON
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intraoperative Orthopedic Joint Assessment Aid | ONN | Class 2 | Neurology | No | 2025-01-07 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2016-08-17 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-01-07 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2026-02-27 |
| Oral Administration Set | PXA | Class 1 | General Hospital | No | 2024-03-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-01-24 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2017-01-24 |
Proprietary Names
Quadsense
Beaver Visitec Internatlional Scleral Marker
Endocuff Vision
EndoSign® Cell collection device
C-STEM
BVI Visitec® Manipulators
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device