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Kaiku Health
EUDAMEDClass IIa (EU MDR)
Ref Kaiku Health major version 7Model Major version 7
by Elekta Oy
Identity
- Trade Name
- Kaiku Health EUDAMED
- Device Name
- Kaiku Health EUDAMED
- Model / Reference
- Major version 7 EUDAMEDKaiku Health major version 7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340201500019 EUDAMED
- Basic UDI-DI
- B-07340201500019 EUDAMED
- EMDN Code
- Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Finland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kaiku Health by Elekta Oy — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07340201500019 | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- Elekta Oy
- EUDAMED SRN
- FI-MF-000012331
Sources (1)
- EUDAMED 6adffe1e-ce43-4f6e-9a0a-f89d42fd19ea 61 fields · synced Oct 7, 2026