Is this your brand? Sign in to claim ownership.
Sign in to claim this brand66 VISION TECH CO., LTD.
China·CN-MF-000030050
Last updated September 17, 2026
What 66 VISION TECH CO., LTD. makes
66 Vision Tech Co., Ltd. manufactures ophthalmic examination and surgical instruments, including slit lamp microscopes for detailed eye imaging, direct ophthalmoscopes for retinal inspection, and retinoscopes for refraction testing. Their product line also covers operation microscopes for precision surgical procedures in ophthalmology, as well as a device identified as Z12129001.
The company’s devices are classified under Class I in the EU regulatory framework and are listed in the eudamed database. The manufacturer is based in China.
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 66 Vision Tech Co., Ltd. manufacture?
66 Vision Tech Co., Ltd. specializes in ophthalmic devices, including instruments for eye examinations and surgery. Their product line covers slit lamp microscopes (used for detailed eye imaging), direct ophthalmoscopes (for retinal inspection), retinoscopes (for refraction testing), and operation microscopes (for precision surgical procedures in ophthalmology). These tools are designed to support diagnostic and surgical needs in eye care.
Where is 66 Vision Tech Co., Ltd. based, and how does that affect its devices?
66 Vision Tech Co., Ltd. is based in China. While the company’s location influences its regulatory compliance processes—such as adhering to EU requirements if devices are marketed there—the specific classification and authorization of its devices depend on their intended purpose and risk level, not the manufacturer’s country of origin.
Which regulatory registries list devices manufactured by 66 Vision Tech Co., Ltd.?
Devices from 66 Vision Tech Co., Ltd. are listed in the eudamed database, which is the EU’s central registry for medical devices. This listing is required for Class I devices marketed within the European Economic Area, ensuring transparency and traceability for regulatory oversight.
How are the ophthalmic devices from 66 Vision Tech Co., Ltd. classified under EU regulations?
The company’s devices fall under Class I in the EU’s medical device classification system. This classification is based on their intended use and risk profile—such as slit lamp microscopes or direct ophthalmoscopes—which are considered low-risk and typically require only basic conformity assessments before market placement.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- 34, Daru Lane, Daru Lane, Suzhou, Suzhou Jiangsu, China
- Website
- 66vision.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- zhou wei
- EUDAMED SRN
- CN-MF-000030050
- FDA FEI Number
- 3003553186
- DUNS Number
- —
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Operation Microscope | XI-AR-000001836 | EUDAMED | Class I | Active |
| Slit Lamp Microscope | YZ5X | EUDAMED | Class I | Active |
| Operation Microscope | XI-AR-000001836 | EUDAMED | Class I | Active |
| Direct Ophthalmoscope | 336289362401 | EUDAMED | Class I | Active |
| Retinoscope | 322177902312 | EUDAMED | Class I | Active |
| Z12129001 | CN-MF-000030050 | EUDAMED | Class I | Active |
Related Companies
Authorised Representatives
- Wellkang Ltd XI
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.