Eighteeth (UDI Acuvision X)
Manufactured by Changzhou Sifary Medical Technology Co., Ltd.
Device Regulatory Overview
The Eighteeth (Model/Catalog Number: Acuvision X) is a medical device manufactured by Changzhou Sifary Medical Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification EPT within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Acuvision X
- Product Code / EMDN
- EPT
- Device Name
- Acuvision X is a surgical microscope intended for the illumination and magnification of the surgical area during surgical procedures (except ophthalmic surgeries).
- Database Sync Date
- 2026-08-09 09:04:48
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Eighteeth?
The registered manufacturer of record for Eighteeth is Changzhou Sifary Medical Technology Co., Ltd..
What is the Primary UDI-DI identifier for Eighteeth?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Acuvision X.
What classification code is assigned to this device?
This device is registered under product classification code EPT.
Similar Classification Devices (EPT)
Other Devices by Changzhou Sifary Medical Technology Co., Ltd.
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