Identity
- Trade Name
- CER-S FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 4 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B972CCZ12050482030 FDA UDI
- 510(k) Number
- K193177 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyser application software
Cer-S by Cardio Calm Srl — Class II — FDA_510K, MDR — listed in FDA GUDID, FDA 510(k), EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Unknown
MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243312 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213861 | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
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Manufacturer
- Manufacturer
- Cardio Calm Srl
- FDA Applicant
- Cardiocalm Srl
Sources (3)
- FDA UDI 51259e02-0ddd-458e-a93d-a2f81b63bec3 59 fields · synced Jun 19, 2026
- FDA 510(k) K243312 1 fields · synced Jun 5, 2026
- EUDAMED 1 fields · synced Jun 1, 2026