S7 / OPMI PROergo (UDI 000000-1254-580)
Manufactured by Carl Zeiss Meditec AG
Device Regulatory Overview
The S7 / OPMI PROergo (Model/Catalog Number: 000000-1254-580) is a medical device manufactured by Carl Zeiss Meditec AG. This product is indexed under FDA Product Code / Category Classification FSO within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 000000-1254-580
- Product Code / EMDN
- FSO
- Device Name
- Database Sync Date
- 2026-08-09 09:11:22
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 S7 / OPMI PROergo?
The registered manufacturer of record for S7 / OPMI PROergo is Carl Zeiss Meditec AG.
What is the Primary UDI-DI identifier for S7 / OPMI PROergo?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 000000-1254-580.
What classification code is assigned to this device?
This device is registered under product classification code FSO.
Similar Classification Devices (FSO)
Other Devices by Carl Zeiss Meditec AG
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