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Q-Nrg
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C09092-11-99Model Q-NRG series
by COSMED Srl
Identity
- Trade Name
- Q-NRG EUDAMEDCOSMED FDA UDI
- Generic Name
- Indirect calorimeter FDA UDI
- Device Name
- Q-NRG EUDAMED
- Model / Reference
- Q-NRG series EUDAMEDC09092-11-99 EUDAMEDQ-NRG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18052400180522 EUDAMEDFDA UDI
- Basic UDI-DI
- 805240018QNRGA2 EUDAMED
- Direct Marketing DI
- 18052400180522 EUDAMED
- 510(k) Number
- K190800 FDA UDI
- FDA Product Code
- BTY FDA UDI
- EMDN Code
- Z1203020404 METABOLISM EQUIPMENT EUDAMED
- GMDN Term
- Indirect calorimeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1890 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Q-Nrg by COSMED Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805240018QNRGA2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- COSMED Srl
- EUDAMED SRN
- IT-MF-000023488
Sources (2)
- EUDAMED c9beb457-e8c0-4922-bd10-930571907028 61 fields · synced May 31, 2026
- FDA UDI 5e064a9d-645d-4512-aa90-f1bce8fa47c3 33 fields · synced May 29, 2026