Q-i2m
Ref C05090-02-11Model Quark series
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805240018Qi2mCM 18052400181321 | Date6 Nov 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Quark series, C05090-02-11
- Primary DI / UDI-DI
- 18052400181321
- Basic UDI-DI
- 805240018Qi2mCM
- Direct Marketing DI
- 18052400181321
- EMDN Code
- Z12159099 Various pneumology and respiratory physiopathology instruments - other
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000023488
Other devices from COSMED Srl
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No