Identity
- Trade Name
- Cardiologs Platform FDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Device Name
- Cardiologs ECG analysis platform FDA UDI
- Model / Reference
- 2.1.xx FDA UDI
- Description
- Cardiologs ECG analysis platform FDA UDI
Identifiers
- Primary DI / UDI-DI
- B273CEA0 FDA UDI
- FDA Product Code
- DPS FDA UDIDQK FDA UDI
- GMDN Term
- Cardiopulmonary physiological parameter analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI870.1425 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary physiological parameter analysis software
Cardiologs Platform by Cardiologs Technologies — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- Office Medic — Vectracor, Inc. · Class II
- RhythmAnalytics — Biofourmis Singapore Pte., Ltd. · Class II
- Premier Heart MCG Analysis API — PREMIER HEART, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cardiologs Technologies
Sources (2)
- FDA UDI 5123f61e-fc4d-4944-a5d7-a36fc4e44d09 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026