GUDIDData
gudid Primary ID: 5167035190

alpha-Amylase EPS Pancreatic (UDI 5167035190)

Manufactured by Roche Diagnostics GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for alpha-Amylase EPS Pancreatic - Primary ID 5167035190

Device Regulatory Overview

The alpha-Amylase EPS Pancreatic (Model/Catalog Number: 5167035190) is a medical device manufactured by Roche Diagnostics GmbH. This product is indexed under FDA Product Code / Category Classification JFJ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
5167035190
Product Code / EMDN
JFJ
Device Name
Database Sync Date
2026-08-09 09:33:50

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 alpha-Amylase EPS Pancreatic?

The registered manufacturer of record for alpha-Amylase EPS Pancreatic is Roche Diagnostics GmbH.

What is the Primary UDI-DI identifier for alpha-Amylase EPS Pancreatic?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5167035190.

What classification code is assigned to this device?

This device is registered under product classification code JFJ.

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