← Back to catalogue
Kaiku Health
EUDAMEDClass IIa (EU MDR)
Ref Kaiku Health major version 8Model Major version 8
Identity
- Trade Name
- Kaiku Health EUDAMED
- Device Name
- Kaiku Health EUDAMED
- Model / Reference
- Major version 8 EUDAMEDKaiku Health major version 8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340201501023 EUDAMED
- Basic UDI-DI
- 073402015BUDI000000001P7 EUDAMED
- EMDN Code
- Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kaiku Health by Elekta Solutions Ab — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 073402015BUDI000000001P7 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elekta Solutions AB
- EUDAMED SRN
- SE-MF-000002125
Sources (1)
- EUDAMED fac80bbb-86e7-4749-a0cb-ce4daf19ed51 61 fields · synced Oct 5, 2026