Identity
- Trade Name
- Coala Heart Monitor EUDAMED
- Device Name
- Coala Heart Monitor EUDAMEDCoala Heart Monitor Pro EUDAMED
- Model / Reference
- 125 EUDAMED101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350002700211 EUDAMED07350002700044 EUDAMED
- Basic UDI-DI
- B-07350002700211 EUDAMEDB-07350002700044 EUDAMED
- EMDN Code
- Z12030601 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Coala Heart Monitor by Coala-Life AB — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07350002700211 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coala Life AB
- EUDAMED SRN
- SE-MF-000005199
Sources (2)
- EUDAMED d81b7d23-9e2f-4228-8597-8fc88fa6fb92 61 fields · synced Jul 8, 2026
- EUDAMED 806feb24-333c-47c1-a136-eae122e58013 61 fields · synced May 18, 2026