Chloe
Ref CHLOE OQ™
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08600072113CHLOEET | Date20 Aug 2023 | StatusActive |
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Chloe
- Model / Reference
- CHLOE OQ™
- Primary DI / UDI-DI
- 00860007211317
- Basic UDI-DI
- 08600072113CHLOEET
- EMDN Code
- Z11069082 Various digital bioimaging management instruments - software accessories
- Device Class
- Class I
- Special Device Type
- Software
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- IL-MF-000033943
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Fairtility, Ltd.
Properties
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No