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Sign in to claim this brandMichelson Diagnostics Limited
United Kingdom (ex Northern Ireland)·GB-MF-000021788
Last updated May 23, 2026
What Michelson Diagnostics Limited makes
Michelson Diagnostics Limited manufactures optical coherence tomography (OCT) devices, including the VivoSight Dx Pro and VivoSight Dx Standoff. These systems are designed for high-resolution imaging of retinal and anterior segment structures, supporting diagnostic evaluations in ophthalmology. The devices enable detailed cross-sectional visualization of the eye, aiding in the assessment of conditions such as macular degeneration and glaucoma.
The company’s portfolio is classified under EU Medical Device Regulation (MDR) as Class IIa devices and is registered in the EU’s eudamed database. These devices are intended for use within the European Union’s regulatory framework. The manufacturer is based in the United Kingdom.
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 Michelson Diagnostics Limited manufacture?
Michelson Diagnostics Limited specializes in optical coherence tomography (OCT) devices, specifically the VivoSight Dx Pro and VivoSight Dx Standoff. These systems are engineered for high-resolution imaging of retinal and anterior segment structures, helping clinicians diagnose and monitor ophthalmic conditions like macular degeneration and glaucoma. The devices provide detailed cross-sectional images of the eye, supporting precise diagnostic evaluations.
Where is Michelson Diagnostics Limited based?
The company is headquartered in the United Kingdom. This location reflects its focus on developing and distributing medical imaging technology within the European market and adhering to relevant regulatory standards.
Which regulatory registries list Michelson Diagnostics Limited’s devices?
Michelson Diagnostics Limited’s devices are registered in the eudamed database, which is the official EU registry for medical devices under the Medical Device Regulation (MDR). This registration ensures transparency and compliance with EU requirements for Class IIa devices.
How are Michelson Diagnostics Limited’s devices classified under EU regulations?
The company’s devices, including the VivoSight Dx Pro and VivoSight Dx Standoff, are classified as Class IIa under the EU Medical Device Regulation (MDR). This classification is based on their intended use for diagnostic imaging of the eye, where they pose moderate risks that require additional scrutiny and conformity assessment procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United Kingdom (ex Northern Ireland)
- Address
- Units 1 & 2, Maidstone Innovation Centre, Gidds Pond Way, Kent, United Kingdom (ex Northern Ireland)
- Website
- www.vivosight.com
- —
- —
- [email protected]
- Phone
- +442083081695
- PRRC Contact
- Jonathan Holmes
- EUDAMED SRN
- GB-MF-000021788
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VivoSight Dx Pro | DX1302 Pro | EUDAMED | Class IIa | Active |
| VivoSight Dx Standoff | 1191.MD.317 | EUDAMED | Class IIa | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Michelson Diagnostics, Ltd. US