Identity
- Trade Name
- Spirolab Plus ESI EUDAMED
- Model / Reference
- MIR100 EUDAMED914034T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990320295 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
Category: Expiratory peak flow meter, digital
Spirolab Plus ESI by MIR - Medical International Research S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Expiratory peak flow meter, digital.
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- MIR — Mir Medical International Research · Class II
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 d161ea3f-967e-4402-aeba-cb34d71600ec 61 fields · synced Jul 10, 2026