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Quark PFT4 ergo
EUDAMEDClass IIa (EU MDR)
Ref C09072-41-99Model Quark series
by COSMED Srl
Identity
- Trade Name
- Quark PFT4 ergo EUDAMED
- Device Name
- Quark PFT EUDAMED
- Model / Reference
- Quark series EUDAMEDC09072-41-99 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18052400181529 EUDAMED
- Basic UDI-DI
- 805240018QPFTA2 EUDAMED
- Direct Marketing DI
- 18052400181529 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 PFT4 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 (1)
- EUDAMED 041756e9-995a-446c-9092-4f47736b2a74 61 fields · synced Sep 18, 2026