Cervibrush+ Lbc -(Endocervical Sampler)
Ref NCA-0780-01AModel Profile LBC
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 | Number05056256NCA0012G 05056256119329 | Date26 Oct 2022 | StatusActive |
Certificates
No certifier 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- Withdrawn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
- Cervibrush+ Profile Lbc -Cervical Sampler -(Double Bagged)
- Model / Reference
- Profile LBC, NCA-0780-01A
- Primary DI / UDI-DI
- 05056256119329
- Basic UDI-DI
- 05056256NCA0012G
- EMDN Code
- A1101 Sample collection neutral swabs
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- GB-MF-000022744
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from CellPath 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