Identity
- Trade Name
- Medikro® Ambi EUDAMED
- Model / Reference
- M9489 EUDAMEDM911 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06420099000844 EUDAMED
- Basic UDI-DI
- 6420099M9489LX EUDAMED
- Direct Marketing DI
- 06420099000844 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
Medikro® Ambi 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 | 6420099M9489LX | 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 (1)
- EUDAMED 802a4ef2-1fce-41f6-90e4-02c41304554c 61 fields · synced Jun 19, 2026