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Sign in to claim this brandTopcon Healthcare Solutions EMEA Oy
US
Last updated May 31, 2026
What Topcon Healthcare Solutions EMEA Oy makes
Topcon Healthcare Solutions EMEA Oy manufactures medical image management systems, specifically the Harmony Referral System.
The company's products are Class I devices and are listed in the FDA UDI registry. The company is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Topcon Healthcare Solutions EMEA Oy manufacture?
Topcon Healthcare Solutions EMEA Oy manufactures medical image management systems, specifically the Harmony Referral System. These systems are designed to facilitate the management and sharing of medical images within healthcare settings.
Where is Topcon Healthcare Solutions EMEA Oy based?
Topcon Healthcare Solutions EMEA Oy is based in the United States. The company operates from its US headquarters, where it develops and manufactures its medical image management systems.
Which regulatory registries list Topcon Healthcare Solutions EMEA Oy's devices?
Topcon Healthcare Solutions EMEA Oy's devices are listed in the FDA UDI registry. This registry tracks unique device identifiers for medical devices sold in the United States, ensuring proper identification and tracking.
How are Topcon Healthcare Solutions EMEA Oy's devices classified?
Topcon Healthcare Solutions EMEA Oy's devices are classified as Class I medical devices. Class I devices are considered low-risk and subject to general controls, which include adherence to labeling, packaging, and manufacturing requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 368366674
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Harmony Referral System | 3.9.1 | FDA UDI | Class I | Active |
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