GUDIDData
Bulk Audit Tool API Access
eudamed_udi Primary ID: 04046955602308

Aesculap (UDI 04046955602308)

Manufactured by Aesculap AG

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Aesculap - Primary ID 04046955602308

Device Regulatory Overview

The Aesculap (Model/Catalog Number: EK538SU) is a medical device manufactured by Aesculap AG. This product is indexed under FDA Product Code / Category Classification K01010103 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 2 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0026-2026 View Full Alert →

AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R....

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-0027-2026 View Full Alert →

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R....

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
EK538SU
Product Code / EMDN
K01010103
Device Name
Trocar and accessories (SU/EO)
Database Sync Date
2026-08-09 16:44:50

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 Aesculap?

The registered manufacturer of record for Aesculap is Aesculap AG.

What is the Primary UDI-DI identifier for Aesculap?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04046955602308.

What classification code is assigned to this device?

This device is registered under product classification code K01010103.

Similar Classification Devices (K01010103)

Other Devices by Aesculap AG

Programmatic Export

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