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Sign in to claim this brandWhat DYSIS MEDICAL LIMITED makes
DYSIS Medical Limited manufactures digital colposcopes, including models such as the DYSIS v3 Digital Colposcope and the DYSIS Ultra series. These devices are designed for cervical cancer screening and diagnostic imaging in gynecological examinations, providing enhanced visualization and imaging capabilities for clinical assessment.
The company’s colposcopes are classified as Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The portfolio is regulated under U.S. medical device standards, ensuring compliance with applicable requirements for diagnostic imaging equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does DYSIS Medical Limited manufacture?
DYSIS Medical Limited specializes in digital colposcopes, which are used primarily for cervical cancer screening and diagnostic imaging during gynecological examinations. These devices enhance visualization and imaging capabilities to aid clinicians in assessing cervical abnormalities.
Where is DYSIS Medical Limited based?
DYSIS Medical Limited is based in the United States. The company’s focus on digital colposcopes aligns with U.S. regulatory standards for medical imaging devices.
Which regulatory registries list DYSIS Medical Limited’s devices?
DYSIS Medical Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for Class II medical devices, which include their colposcopes.
How are DYSIS Medical Limited’s devices classified under medical device regulations?
DYSIS Medical Limited’s colposcopes fall under Class II medical device classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as imaging devices used in diagnostic procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dysismedical.com
- —
- —
- [email protected]
- Phone
- +4401315163944
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 424589138
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DYSIS v3 Digital Colposcope | DYS302 - DYSIS v3 BASE Assembly | FDA UDI | Class II | Active |
| DYSIS v3 Digital Colposcope | DYS302 - DYSIS v3 ARM Assembly | FDA UDI | Class II | Active |
| DYSIS Ultra 2.0 | DYS403 | FDA UDI | Class II | Active |
| DYSIS Ultra | DYS402 - DYSIS Ultra | FDA UDI | Class II | Active |
| DYSIS v3 Digital Coploscope | MON001 - DYSIS v3 19" Monitor Assembly | FDA UDI | Class II | Active |
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