MINIVAC (UDI R00)

Manufactured by Ecleris

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The MINIVAC (Model/Catalog Number: R00) is a medical device manufactured by Ecleris. This product is indexed under FDA Product Code / Category Classification GFE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R00
Product Code / EMDN: GFE
Device Name: MINIVAC
Database Sync Date: 2026-08-09 09:18:01

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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Frequently Asked Questions

Who is the primary manufacturer of MINIVAC?

The registered manufacturer of record for MINIVAC is Ecleris.

What is the Primary UDI-DI identifier for MINIVAC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is R00.

What classification code is assigned to this device?

This device is registered under product classification code GFE.

Similar Classification Devices (GFE)

Other Devices by Ecleris

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