Eyer 2 Basic

GUDID 07908616100097

Eyer 2 Basic

PHELCOM TECHNOLOGIES SA

Ophthalmic fundus camera

• Primary Device ID: 07908616100097
• NIH Device Record Key: e7e805f2-5669-43cf-a9b2-84ed6095a1b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eyer 2 Basic
• Version Model Number: Eyer 2 Basic
• Company DUNS: 945005233
• Company Name: PHELCOM TECHNOLOGIES SA
• 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: false
• 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	07908616100097 [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: 2024-10-01
• Device Publish Date: 2024-09-23

Devices Manufactured by PHELCOM TECHNOLOGIES SA

• 07908616100097 - Eyer 2 Basic: 2024-10-01Eyer 2 Basic
• 07908616100097 - Eyer 2 Basic: 2024-10-01 Eyer 2 Basic
• 07908616100011 - Eyer: 2023-05-05 Eyer Retinal Camera NM-STD
• 07908616100042 - Eyer: 2023-05-05 Eyer Retinal Camera M-STD