Identity
- Trade Name
- Spirolab EUDAMED
- Model / Reference
- MIR080 EUDAMED911080E5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990321094 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
Spirolab 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 | 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 36bfa430-04a7-446c-b977-4b63e47d7cd6 61 fields · synced Jul 27, 2026