Identity
- Trade Name
- Coala Heart Monitor EUDAMED
- Device Name
- Coala Heart Monitor OTC EUDAMED
- Model / Reference
- 100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350002700235 EUDAMED
- Basic UDI-DI
- B-07350002700235 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-07350002700235 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coala Life AB
- EUDAMED SRN
- SE-MF-000005199
Sources (1)
- EUDAMED c6fd3468-9c9e-4b07-824c-2b49418cb829 61 fields · synced Oct 6, 2026