Viva-ProE 6003-760

GUDID 03701700860358

VitalScientific B.V.

Multiple clinical chemistry analyser IVD, laboratory

• Primary Device ID: 03701700860358
• NIH Device Record Key: 16d6f3f7-469b-49a1-8c75-0c3028822355
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viva-ProE
• Version Model Number: Viva-ProE
• Catalog Number: 6003-760
• Company DUNS: 494028946
• Company Name: VitalScientific B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	03701700860358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102647

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), 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: 2025-05-08
• Device Publish Date: 2025-04-30

Devices Manufactured by VitalScientific B.V.

• 03701700860396 - Selectra: 2025-05-14
• 03701700860419 - Selectra: 2025-05-14
• 03701700860358 - Viva-ProE: 2025-05-08
• 03701700860358 - Viva-ProE: 2025-05-08