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Quark PFT ergo
EUDAMEDClass IIa (EU MDR)
Ref C09073-12-99Model Quark seriesRef C09074-11-99
by COSMED Srl
Identity
- Trade Name
- Quark PFT ergo EUDAMED
- Device Name
- Quark CPET EUDAMEDQuark RMR EUDAMED
- Model / Reference
- Quark series EUDAMEDC09073-12-99 EUDAMEDC09074-11-99 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18052400181536 EUDAMED18052400181543 EUDAMED
- Basic UDI-DI
- 805240018QCPET6D EUDAMED805240018QRMRAV EUDAMED
- Direct Marketing DI
- 18052400181536 EUDAMED18052400181543 EUDAMED
- EMDN Code
- Z12050101 STRESS ANALYSIS SYSTEMS EUDAMEDZ12159099 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER 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 PFT 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 | 805240018QCPET6D | Class IIa | Active |
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Manufacturer
- Manufacturer
- COSMED Srl
- EUDAMED SRN
- IT-MF-000023488
Sources (2)
- EUDAMED 00392bcc-eae7-49bb-a4c1-e605bc3ab70d 61 fields · synced Aug 1, 2026
- EUDAMED d1348a33-4e23-4f76-a8b4-da9387ffeef8 61 fields · synced May 19, 2026