GUDIDData
emdn_classification Primary ID: W0103020401

AGGREGATION REAGENTS (UDI W0103020401)

Manufactured by

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AGGREGATION REAGENTS - Primary ID W0103020401

Device Regulatory Overview

The AGGREGATION REAGENTS (Model/Catalog Number: Unspecified) is a medical device manufactured by . This product is indexed under FDA Product Code / Category Classification W0103020401 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-2753-2026 View Full Alert →

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ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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Technical Specifications

Model Number
N/A
Product Code / EMDN
W0103020401
Device Name
AGGREGATION REAGENTS
Database Sync Date
2026-08-09 16:18:37

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 AGGREGATION REAGENTS?

The registered manufacturer of record for AGGREGATION REAGENTS is .

What is the Primary UDI-DI identifier for AGGREGATION REAGENTS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is W0103020401.

What classification code is assigned to this device?

This device is registered under product classification code W0103020401.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint