gudid Primary ID: Intro Pack

Calcigel (UDI Intro Pack)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Calcigel (Model/Catalog Number: Intro Pack) is a medical device manufactured by PREVEST DENPRO LIMITED. This product is indexed under FDA Product Code / Category Classification EJK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Intro Pack
Product Code / EMDN: EJK
Device Name
Database Sync Date: 2026-08-09 09:01:11

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 Calcigel?

The registered manufacturer of record for Calcigel is PREVEST DENPRO LIMITED.

What is the Primary UDI-DI identifier for Calcigel?

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

What classification code is assigned to this device?

This device is registered under product classification code EJK.

Similar Classification Devices (EJK)

Other Devices by PREVEST DENPRO LIMITED

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