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Quark PFT3
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref C09072-32-99Model Quark series510(k) K001174
by COSMED Srl
Identity
- Trade Name
- Quark PFT3 EUDAMED
- Device Name
- Quark PFT EUDAMED
- Model / Reference
- Quark series EUDAMEDC09072-32-99 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18052400181499 EUDAMED
- Basic UDI-DI
- 805240018QPFTA2 EUDAMED
- Direct Marketing DI
- 18052400181499 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 PFT3 by COSMED Srl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120146 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K001174 | Class IIa | Active |
| 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 98ca1b78-a759-49ee-a3d7-cb7afd8ca0cb 85 fields · synced Jun 18, 2026
- FDA 510(k) K120146 1 fields · synced May 18, 2026