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Q-Nrg+
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref C09092-42-99Model Q-NRG seriesRef C09092-01-99Ref C09092-32-99510(k) K190800Ref C09094-01-99
by COSMED Srl
Identity
- Trade Name
- Q-NRG+ EUDAMEDQ-NRG EUDAMEDQ EUDAMED
- Device Name
- Q-NRG EUDAMEDQ EUDAMED
- Model / Reference
- Q-NRG series EUDAMEDC09092-42-99 EUDAMEDC09092-01-99 EUDAMEDC09092-32-99 EUDAMEDC09094-01-99 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18052400181307 EUDAMED18052400180508 EUDAMED18052400181291 EUDAMED18052400181581 EUDAMED
- Basic UDI-DI
- 805240018QNRGA2 EUDAMED805240018QSPIROD8 EUDAMED
- Direct Marketing DI
- 18052400181307 EUDAMED18052400180508 EUDAMED18052400181291 EUDAMED18052400181581 EUDAMED
- 510(k) Number
- K190800 FDA 510(k)
- FDA Product Code
- BTY FDA 510(k)
- EMDN Code
- Z1203020404 METABOLISM EQUIPMENT EUDAMEDZ12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1890 FDA 510(k)
- Regulation Number
- 868.1890 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Q-Nrg+ 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190800 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805240018QNRGA2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- COSMED Srl
- EUDAMED SRN
- IT-MF-000023488
Sources (5)
- EUDAMED 6efe26ca-c258-496a-ad5b-e5906932c0b1 61 fields · synced Sep 18, 2026
- EUDAMED 6bdd1db6-d838-4b06-a750-eae1c7cd5e24 61 fields · synced May 18, 2026
- EUDAMED 9d7c79d1-1d03-4999-a70e-702975eac0be 61 fields · synced May 18, 2026
- FDA 510(k) K190800 24 fields · synced May 18, 2026
- EUDAMED ad142768-3e00-4d3d-9fbf-4a8bdbbe9bc8 61 fields · synced Jul 24, 2026