GUDIDData
eudamed_udi Primary ID: EPRCA1000753

Hand Pour Resin PR-1 (UDI EPRCA1000753)

Manufactured by pro3dure medical GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Hand Pour Resin PR-1 - Primary ID EPRCA1000753

Device Regulatory Overview

The Hand Pour Resin PR-1 (Model/Catalog Number: A1000753) is a medical device manufactured by pro3dure medical GmbH. This product is indexed under FDA Product Code / Category Classification Y214580 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
A1000753
Product Code / EMDN
Y214580
Device Name
Long-Term Earmold Resins
Database Sync Date
2026-08-09 16:29:00

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 Hand Pour Resin PR-1?

The registered manufacturer of record for Hand Pour Resin PR-1 is pro3dure medical GmbH.

What is the Primary UDI-DI identifier for Hand Pour Resin PR-1?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is EPRCA1000753.

What classification code is assigned to this device?

This device is registered under product classification code Y214580.

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