ME-CHECK 4 ME-CHECK 4

GUDID 08056389701405

ESPANSIONE MARKETING SPA

Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular Multi-purpose digital medical camera lens, extraocular

• Primary Device ID: 08056389701405
• NIH Device Record Key: 3eb2270c-58f6-4351-82a8-46edd341d3ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ME-CHECK 4
• Version Model Number: ME-CHECK 4
• Catalog Number: ME-CHECK 4
• Company DUNS: 339474539
• Company Name: ESPANSIONE MARKETING SPA
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056389701405 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-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: 2023-04-13
• Device Publish Date: 2023-04-05

Devices Manufactured by ESPANSIONE MARKETING SPA

• 08056389701351 - E-LIGHT LINE: 2023-04-19
• 08056389701368 - E-LIGHT LINE: 2023-04-19
• 08056389701375 - E-LIGHT LINE: 2023-04-19
• 08056389701412 - E-LIGHT LINE: 2023-04-19
• 08056389701405 - ME-CHECK 4: 2023-04-13
• 08056389701405 - ME-CHECK 4: 2023-04-13
• 08056389700644 - MY MASK-E: 2022-07-26
• 08056389700651 - MY MASK-E: 2022-07-26
• 08056389700668 - MY MASK-E: 2022-07-26