Dental Retractor
by Huanghua Promisee Dental Co.Ltd. 25 variants
Ref CR13SModel CR01L,CR01S,CR02L,CR02M,CR02S,CR03,CR03L,CR03M,CR03S,CR04,CR04L,CR04S,CR05,CR05L,CR05S,CR06,CR07,CR09,CR09L,CR09M,CR09S,CR11L,CR11M,CR11S,CR12L,CR12M,CR12S,CR10,CR10M,CR10S,CR08,CR08L,CR08S,CR0802L,CR0802S,MP01,MP01L,MP01M,MP01S,MP02,MP02L,MP02M,MP02S
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 | Number69544540DERE001M3 06954454013496 | Date6 Mar 2025 | 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- Withdrawn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
- Model / Reference
- CR01L, CR01S, CR02L, CR02M, CR02S, CR03, CR03L, CR03M, CR03S, CR04, CR04L, CR04S, CR05, CR05L, CR05S, CR06, CR07, CR09, CR09L, CR09M, CR09S, CR11L, CR11M, CR11S, CR12L, CR12M, CR12S, CR10, CR10M, CR10S, CR08, CR08L, CR08S, CR0802L, CR0802S, MP01, MP01L, MP01M, MP01S, MP02, MP02L, MP02M, MP02S, CR13S
- Primary DI / UDI-DI
- 06954454013496
- Basic UDI-DI
- 69544540DERE001M3
- EMDN Code
- Q010204 Retraction wires and gingival retractors
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000014766
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Huanghua Promisee Dental Co.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