Companies
Airdoc
develops AI-based eye-screening technology, including diabetic-retinopathy and broader ophthalmic disease detection, as part of China's growing ophthalmic AI diagnostics base.
- Country
- China
Commercial
AI eye-screening technology
Coverage
| CN | EU | US | |
|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Certification | Class III medical device registration for Airdoc-AIFUNDUS (2.0) from NMPA (April 2025) | hkexnews.hk |
| Certification | Class II medical device registration for AI-FUNDUSCAMERA-P (Model: AI-FD16U) from NMPA (January 2025) | hkexnews.hk |
| Certification | Class II medical device registration for AI-FUNDUSCAMERA-M (AI-FD16M) from NMPA (August 2025) | hkexnews.hk |
| Certification | Class II medical device registration for AI-FUNDUSCAMERA-H (AI-FD16H-VAD) (fundus camera module in August 2024, slit-lamp module in July 2025) | hkexnews.hk |
| Regulatory approval | EU CE MDR certification for Airdoc-AIFUNDUS (1.0) (announced January 2024) | eqs-news.com |
| Regulatory approval | US FDA certification for Retinal Detection AI (as of end of 2025 Reporting Period) | hkexnews.hk |
| Production site | Manufacturing base in the High-Tech Development Zone of Changsha, Hunan | hkexnews.hk |
| Capacity | Approximately 100,000 fundus cameras per year | hkexnews.hk |
| Revenue | RMB 173.262 million for the year ended December 31, 2025 | hkexnews.hk |
Independent sources: eqs-news.com · hkexnews.hk
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| AI optical coherence tomography screening | diagnostics-medtech | Low | → |
Compiled by BIOECON from primary sources.
Compliance
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