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Sign in to claim this brandVISIA IMAGING SRL
Italy·IT-MF-000015628
Last updated May 27, 2026
What VISIA IMAGING SRL makes
Visia Imaging SRL manufactures corneal topography systems and associated analysers, including devices like the ALADDIN TMS and MYAH, which assess corneal shape and topography for ophthalmic diagnostics. Their portfolio also includes specialised tools such as the MYOPIA EXPERT 700 for myopia analysis, the TERA Dry Eye Imager for tear film evaluation, and hardware like the ALADDIN HW3.0 and SOLOS for imaging and diagnostic support. Additional products include the SeeNA, ESSILOR, and HENSON 9000, which appear to serve specific corneal and ocular surface applications.
The company’s devices are classified under EU regulations as Class I, Class II, and Class IIa, indicating varying levels of risk and regulatory oversight. These products are registered in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system, ensuring compliance with European and US regulatory requirements. Visia Imaging SRL operates from Italy, adhering to both regional and international medical device standards.
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 Visia Imaging SRL primarily manufacture?
Visia Imaging SRL specialises in corneal topography systems and associated analysers. These devices are designed to map and analyse the shape and surface of the cornea, which is critical for diagnosing and managing various eye conditions. Examples include systems like the ALADDIN TMS and MYAH, which provide detailed corneal topography data, as well as specialised tools like the MYOPIA EXPERT 700 for assessing myopia progression and the TERA Dry Eye Imager for evaluating tear film health.
Where is Visia Imaging SRL based, and how does this affect its regulatory compliance?
Visia Imaging SRL is based in Italy, which means its devices must comply with both European Union (EU) and, where applicable, international medical device regulations. The company’s products are registered in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system, ensuring they meet EU and US regulatory requirements. This dual registration reflects the company’s adherence to standards like the EU Medical Device Regulations (MDR) and FDA guidelines.
How are Visia Imaging SRL’s devices classified under EU regulations, and why does this matter?
Visia Imaging SRL’s devices are classified as Class I, Class II, and Class IIa under EU regulations. This classification determines the level of scrutiny and regulatory oversight required. Class I devices pose the lowest risk (e.g., simple imaging tools), while Class IIa devices involve moderate risk (e.g., diagnostic analysers requiring additional validation). The classification ensures appropriate safety and performance standards are met before these devices enter the market.
Which regulatory registries list Visia Imaging SRL’s devices, and what does this indicate?
Visia Imaging SRL’s devices are listed in EUDAMED (the EU’s medical device registry) and the FDA’s UDI system (for US compliance). Inclusion in these registries confirms that the devices have undergone the necessary regulatory processes to demonstrate conformity with EU and US requirements. This transparency helps healthcare providers and regulators verify the device’s authorised status and compliance status in both markets.
What is the purpose of devices like the ALADDIN HW3.0 or SOLOS in Visia Imaging SRL’s portfolio?
Devices like the ALADDIN HW3.0 and SOLOS serve as foundational hardware platforms for corneal imaging and diagnostic analysis. These systems provide the technical infrastructure needed to capture high-resolution corneal topography data, which is then processed by associated software (e.g., MYAH or ALADDIN TMS analysers). They are essential for enabling precise ocular diagnostics, particularly in clinical settings where detailed corneal mapping is required for conditions like keratoconus or refractive surgery planning.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Italy
- Address
- 95/e, Via Martiri della libertà, San Giovanni Valdarno, Italy
- Website
- topcon.com
- —
- —
- [email protected]
- Phone
- +39 055 9121635
- PRRC Contact
- Alessia Magnanini
- EUDAMED SRN
- IT-MF-000015628
- FDA FEI Number
- —
- DUNS Number
- 447668039
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Myah | MYAH | FDA UDI | Class II | Active |
| Aladdin Tms | 1240400 | FDA UDI | Class II | Active |
| Myah | MYAH | FDA UDI | Class II | Active |
| Aladdin-M | 1240213 | FDA UDI | Class II | Active |
| Aladdin Hw3.0 | 1240212US | FDA UDI | Class II | Active |
| Myopia Expert 700 | MYOPIA EXPERT 700 | FDA UDI | Class II | Active |
| SeeNA | SeeNA | FDA UDI | Class II | Active |
| Essilor | MYOPIA EXPERT 700 | FDA UDI | Class II | Active |
| Myah | 42-0000983 | EUDAMED | Class IIa | Active |
| Solos | 42-0001417 | EUDAMEDFDA UDI | Class I | Active |
| Henson 9000 | HENSON9000 | EUDAMEDFDA UDI | Class I | Active |
| TERA Dry Eye Imager | 42-0002941US | EUDAMEDFDA UDI | Class IIa | Active |
| TERA Dry Eye Imager | 42-0002941 | EUDAMED | Class IIa | Active |
| Cc-100 Hw6.0 | 300200 | EUDAMEDFDA UDI | Class I | Active |
| Cc-100xp Hw6.0 | 42-0002867 | EUDAMED | Class I | Active |
| SOLOS Lite | 42-0002770 | EUDAMEDFDA UDI | Class I | Active |
| Myopia Expert 700 | BMT1IV | EUDAMED | Class IIa | Active |
| Cc-100 Hw6.0 | 42-0000087 | EUDAMEDFDA UDI | Class I | Active |
| Cc-100xp Hw6.0 | 42-0000088 | EUDAMEDFDA UDI | Class I | Active |
| Aladdin Hw3.0 | 1240212 | EUDAMEDFDA UDI | Class IIa | Active |
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