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eudamed_udi Primary ID: D-441350NU

SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2 (UDI D-441350NU)

Manufactured by Beckman Coulter Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2 - Primary ID D-441350NU

Device Regulatory Overview

The SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2 (Model/Catalog Number: 441350) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification W0101050303 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0071-2026 View Full Alert →

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ID: Z-0441-2026 View Full Alert →

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706...

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ID: Z-0032-2026 View Full Alert →

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clin...

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Technical Specifications

Model Number
441350
Product Code / EMDN
W0101050303
Device Name
SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2
Database Sync Date
2026-08-09 18:28:44

Full Regulatory Attributes

🔒 Token Gated 
{
    "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 SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2?

The registered manufacturer of record for SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2 is Beckman Coulter Inc..

What is the Primary UDI-DI identifier for SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-441350NU.

What classification code is assigned to this device?

This device is registered under product classification code W0101050303.

Similar Classification Devices (W0101050303)

Other Devices by Beckman Coulter Inc.

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