Centri™ Base X Heat Cure Powder
by WHW Plastics Limited 17 variants
Ref 01CBXH-450-TV, 01CBXH-25-NP, 01CBXH-25-NPV, 01CBXH-450-NPV, 01CBXH-10-T, 01CBXH-10-NP, 01CBXH-SAM-C, 01CBXH-450-LPV, 01CBXH-10-TV, 01CBXH-25-LPV, 01CBXH-3000-TV, 01CBXH-25-TV, 01CBXH-450-T, 01CBXH-50-NP, 01CBXH-3000-LP, 01CBXH-3000-T, 01CBXH-3000-LPV, 01CBXH-450-NP, 01CBXH-50-LP, 01CBXH-3000-NPV, 01CBXH-50-C, 01CBXH-25-C, 01CBXH-SAM-T, 01CBXH-SAM-LPV, 01CBXH-25-LP, 01CBXH-450-C
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 | Number506061605centri00000001KD | Date21 Jan 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- Withdrawn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
- Device Materials for removable dental appliances
- Model / Reference
- 01CBXH-450-TV, 01CBXH-25-NP, 01CBXH-25-NPV, 01CBXH-450-NPV, 01CBXH-10-T, 01CBXH-10-NP, 01CBXH-SAM-C, 01CBXH-450-LPV, 01CBXH-10-TV, 01CBXH-25-LPV, 01CBXH-3000-TV, 01CBXH-25-TV, 01CBXH-450-T, 01CBXH-50-NP, 01CBXH-3000-LP, 01CBXH-3000-T, 01CBXH-3000-LPV, 01CBXH-450-NP, 01CBXH-50-LP, 01CBXH-3000-NPV, 01CBXH-50-C, 01CBXH-25-C, 01CBXH-SAM-T, 01CBXH-SAM-LPV, 01CBXH-25-LP, 01CBXH-450-C
- Primary DI / UDI-DI
- 05060616050481, 05060616051648, 05060616051600, 05060616050474, 05060616051587, 05060616051570, 05060616051693, 05060616050467, 05060616051549, 05060616051594, 05060616050559, 05060616051617, 05060616050528, 05060616050658, 05060616050573, 05060616050597, 05060616050535, 05060616050511, 05060616050641, 05060616050542, 05060616050634, 05060616051624, 05060616051723, 05060616051662, 05060616051631, 05060616050498
- Basic UDI-DI
- 506061605centri00000001KD
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000019139
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from WHW Plastics Limited
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