PhenoMATRIX WLAB-PHENOMATRIX

GUDID 58059796360857

PhenoMATRIX

COPAN WASP SRL

Histology/cytology/microbiology image-analysis interpretive software IVD

• Primary Device ID: 58059796360857
• NIH Device Record Key: abe52470-3b64-4f9f-a74f-69e30e32362a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhenoMATRIX
• Version Model Number: WLAB-PHENOMATRIX
• Catalog Number: WLAB-PHENOMATRIX
• Company DUNS: 434263590
• Company Name: COPAN WASP SRL
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com
• Phone: +390302687218
• Email: wasp@copangroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	58059796360857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251511

FDA Product Code

• PPU: Microbial Colony Image Assessment System

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: 2026-02-23
• Device Publish Date: 2026-02-13

Devices Manufactured by COPAN WASP SRL

• 58059796360857 - PhenoMATRIX: 2026-02-23PhenoMATRIX
• 58059796360857 - PhenoMATRIX: 2026-02-23 PhenoMATRIX
• 58059796363506 - WASP®: 2024-11-29 WASP®
• 58059796363933 - WASPLab®: 2024-06-12 WASPLab®
• 58059796363940 - WASPLab® Conveyor: 2024-06-12 WASPLab® Conveyor
• 58059796363957 - WASPLab® Single Incubator: 2024-06-12 WASPLab® Single Incubator
• 58059796363964 - WASPLab® Double Incubator: 2024-06-12 WASPLab® Double Incubator
• 58050148217973 - Colibrí™ Primary Tube with Water: 2024-02-08 Colibrí™ Primary Tube with Water
• 58052870817964 - Colibrí™ Primary Tube with Saline: 2024-02-08 Colibrí™ Primary Tube with Saline