Identity
- Trade Name
- Spirolab Plus EUDAMED
- Model / Reference
- MIR100 EUDAMED914030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990320547 EUDAMED
- Basic UDI-DI
- 805299032100DB EUDAMED
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Spirolab Plus by MIR - Medical International Research S.p.A. — 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 | 805299032100DB | Class IIa | Active |
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Manufacturer
- Manufacturer
- MIR - Medical International Research S.p.A.
- EUDAMED SRN
- IT-MF-000014026
Sources (1)
- EUDAMED f69d7412-fa7a-4d67-bac8-0bd9f786605e 61 fields · synced Jul 12, 2026