Identity
- Trade Name
- Medikro Spirometry Software EUDAMED
- Device Name
- Medikro Spirometry Software EUDAMED
- Model / Reference
- M9831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06420099000066 EUDAMED
- Basic UDI-DI
- 6420099M9831LL EUDAMED
- Direct Marketing DI
- 06420099000066 EUDAMED
- EMDN Code
- Z12150192 SPIROMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medikro Spirometry Software 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 | 6420099M9831LL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (1)
- EUDAMED 2796b162-f1c4-4b47-bf1a-ba7d9b0a2cb3 61 fields · synced Jun 18, 2026