Identity
- Trade Name
- Medikro Duo EUDAMED
- Device Name
- Medikro Duo EUDAMED
- Model / Reference
- M9497 EUDAMEDM920 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06420099000868 EUDAMED
- Basic UDI-DI
- 6420099M9497LW EUDAMED
- Direct Marketing DI
- 06420099000868 EUDAMED
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medikro Duo by Medikro Oy — 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 | 6420099M9497LW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (1)
- EUDAMED 2b31e919-e9d9-4bed-ba54-e86649d1ddb0 61 fields · synced Jun 19, 2026