← Back to catalogue
Quark PFT1
EUDAMEDClass IIa (EU MDR)
Ref C09071-11-99Model Quark series
by COSMED Srl
Identity
- Trade Name
- Quark PFT1 EUDAMED
- Device Name
- Quark SPIRO EUDAMED
- Model / Reference
- Quark series EUDAMEDC09071-11-99 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18052400181475 EUDAMED
- Basic UDI-DI
- 805240018QSpiroTK EUDAMED
- Direct Marketing DI
- 18052400181475 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 PFT1 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 | 805240018QSpiroTK | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- COSMED Srl
- EUDAMED SRN
- IT-MF-000023488
Sources (1)
- EUDAMED 72b76b34-2cf2-46d5-ae78-5c04d1399831 61 fields · synced Jun 19, 2026