CER-S CCZ1205048208

GUDID B972CCZ12050482080

CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.

CARDIO CALM SRL

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: B972CCZ12050482080
• NIH Device Record Key: 1594fe58-721f-4625-a2c7-e8087e2b1e8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CER-S
• Version Model Number: 4
• Catalog Number: CCZ1205048208
• Company DUNS: 431076243
• Company Name: CARDIO CALM 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: 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

Customer Support Contacts

• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com
• Phone: +390308140128
• Email: supporto@cardiocalm.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B972CCZ12050482080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243312

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2025-03-10
• Device Publish Date: 2025-02-28

On-Brand Devices [CER-S]

• B972CCZ12050482030: CER-S is stand-alone software medical device, providing advanced solutions for importing, analyz
• B972CCZ12050482050: CER-S is stand-alone software medical device, providing advanced solutions for importing, analyz
• B972CCZ12050482080: CER-S is stand-alone software medical device, providing advanced solutions for importing, analyz