CER-S CCZ1205048205

GUDID B972CCZ12050482050

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 IDB972CCZ12050482050
NIH Device Record Key87b1b62a-603b-4174-8305-1039b558c288
Commercial Distribution StatusIn Commercial Distribution
Brand NameCER-S
Version Model Number4
Catalog NumberCCZ1205048205
Company DUNS431076243
Company NameCARDIO CALM SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39 0308140128
Emailsupporto@cardiocalm.com
Phone+39 0308140128
Emailsupporto@cardiocalm.com
Phone+39 0308140128
Emailsupporto@cardiocalm.com
Phone+39 0308140128
Emailsupporto@cardiocalm.com
Phone+39 0308140128
Emailsupporto@cardiocalm.com
Phone+39 0308140128
Emailsupporto@cardiocalm.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB972CCZ12050482050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-07
Device Publish Date2022-05-30

On-Brand Devices [CER-S]

B972CCZ12050482030CER-S is stand-alone software medical device, providing advanced solutions for importing, analyz
B972CCZ12050482050CER-S is stand-alone software medical device, providing advanced solutions for importing, analyz

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