Identity
- Trade Name
- Spirolab EUDAMED
- Model / Reference
- MIR080 EUDAMED911081E5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990321100 EUDAMED
- Basic UDI-DI
- 805299032080DW 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 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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- Model 4000 — Vitalograph Ireland, Ltd. · Class II
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- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- 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 | 805299032080DW | Class IIa | Active |
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Manufacturer
- Manufacturer
- MIR - Medical International Research S.p.A.
- EUDAMED SRN
- IT-MF-000014026
Sources (1)
- EUDAMED 02b48a78-46ec-41b9-bd9f-0a1650b077d6 61 fields · synced Jun 18, 2026