Identity
- Trade Name
- Coala Heart Monitor US Rx FDA UDI
- Generic Name
- Phonocardiograph FDA UDI
- Device Name
- The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician. FDA UDI
- Model / Reference
- 201 FDA UDI
- Description
- The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 07350002700105 FDA UDI
- 510(k) Number
- K182040 FDA UDI
- FDA Product Code
- DXH FDA UDI
- GMDN Term
- Phonocardiograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiograph, home-usePhonocardiograph
Coala Heart Monitor US Rx by Coala-Life AB — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Coala-Life AB
Sources (2)
- FDA UDI c5f59a31-3829-4e36-a508-2a58cc441e86 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026