HELMED® Automated IFA Processor REF.HEL-1000.US

GUDID 04250289513531

Aesku.Diagnostics GmbH & Co. KG

Specimen processing instrument IVD

• Primary Device ID: 04250289513531
• NIH Device Record Key: 09a263f9-f7a4-4791-ab43-524cafd071b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELMED® Automated IFA Processor
• Version Model Number: REF.HEL-1000.US
• Catalog Number: REF.HEL-1000.US
• Company DUNS: 341714388
• Company Name: Aesku.Diagnostics GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250289513531 [Primary]

FDA Product Code

• JQW: Station, Pipetting And Diluting, For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

On-Brand Devices [HELMED® Automated IFA Processor]

• 04250289512565: REF.HEL-1000
• 04250289513531: REF.HEL-1000.US