Identity
- Model / Reference
- M9474 EUDAMEDM9278 EUDAMEDM9278-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06420099000981 EUDAMED06420099000912 EUDAMED
- Basic UDI-DI
- 6420099M9474LJ EUDAMED
- EMDN Code
- Z12150199 SPIROMETRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
M9278 by Medikro Oy — Class I — 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 | 6420099M9474LJ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (2)
- EUDAMED 71b9ee95-2d2d-4c98-a6ec-428b42bdd287 61 fields · synced Jul 26, 2026
- EUDAMED e70c160f-214d-4038-be6b-3f9eb771e0ba 61 fields · synced May 18, 2026