Viva-ProE®

GUDID 03661540600357

ELITechGroup B.V.

Multiple clinical chemistry analyser IVD, laboratory, semi-automated

• Primary Device ID: 03661540600357
• NIH Device Record Key: 63adb7bc-d1c6-4b88-9655-0cb02eceea7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viva-ProE®
• Version Model Number: 6003-760
• Company DUNS: 415733737
• Company Name: ELITechGroup 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	03661540600357 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-04-21

Devices Manufactured by ELITechGroup B.V.

• 03661540700064 - Excyte®: 2022-09-16
• 03661540700071 - Excyte®: 2022-09-16
• 03661540700118 - Excyte®: 2022-09-16
• 03661540700125 - Excyte®: 2022-09-16
• 03661540700446 - Excyte®: 2022-08-05
• 03661540700606 - Excyte®: 2021-12-28
• 03661540700613 - Excyte®: 2021-12-28
• 03661540700668 - Excyte®: 2021-12-28