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Quark PFT2 ergo
EUDAMEDClass IIa (EU MDR)
Ref C09072-21-99Model Quark seriesRef C09072-22-99
by COSMED Srl
Identity
- Trade Name
- Quark PFT2 ergo EUDAMEDQuark PFT2 EUDAMED
- Device Name
- Quark PFT EUDAMED
- Model / Reference
- Quark series EUDAMEDC09072-21-99 EUDAMEDC09072-22-99 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18052400181512 EUDAMED18052400181482 EUDAMED
- Basic UDI-DI
- 805240018QPFTA2 EUDAMED
- Direct Marketing DI
- 18052400181512 EUDAMED18052400181482 EUDAMED
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Quark PFT2 ergo by COSMED Srl — 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 | 805240018QPFTA2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- COSMED Srl
- EUDAMED SRN
- IT-MF-000023488
Sources (2)
- EUDAMED b823a7e0-8642-4d0f-8256-9212dc147ad9 61 fields · synced Jul 30, 2026
- EUDAMED b5c69de9-e594-4e1f-bc0d-be6e0226ed3d 61 fields · synced May 18, 2026