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Quark RMR
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C09074-01-99Model Quark series
by COSMED Srl
Identity
- Trade Name
- Quark RMR EUDAMEDCOSMED FDA UDI
- Generic Name
- Indirect calorimeter FDA UDI
- Device Name
- Quark RMR EUDAMEDThe COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions. FDA UDI
- Model / Reference
- Quark series EUDAMEDC09074-01-99 EUDAMEDQuark RMR FDA UDI
- Description
- The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18052400180171 EUDAMEDFDA UDI
- Basic UDI-DI
- 805240018QRMRAV EUDAMED
- Direct Marketing DI
- 18052400180171 EUDAMED
- 510(k) Number
- K120146 FDA UDI
- FDA Product Code
- BTY FDA UDICBK FDA UDI
- EMDN Code
- Z12159099 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Indirect calorimeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1890 FDA UDI868.5895 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
Quark RMR 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 | 805240018QRMRAV | 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 e0ed7dc4-7ca6-4a2c-9981-4b04db5d5f73 61 fields · synced Jul 19, 2026
- FDA UDI e36794c4-74ec-46c9-91c9-31cf073bf98b 35 fields · synced May 29, 2026