Identity
- Device Name
- Medikro® Spirometry Software EUDAMED
- Model / Reference
- M9831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-M9831SL EUDAMED
- Basic UDI-DI
- B-M9831SL EUDAMED
- EMDN Code
- Z12150192 SPIROMETRY 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
Medikro® Spirometry Software by Medikro Oy — 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-M9831SL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (1)
- EUDAMED ae859e33-9340-4d54-abae-294eb4ee3719 61 fields · synced Jul 11, 2026