SanctuaryTM ComfiTract Latex Free Cheek Retractor 75mm (Medium)
by Sanctuary Health Sdn Bhd 2 variants
Ref CR002-S63-P319Model Latex-Free Cheek Retractor
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 | Number955551401CCRSH01K5 09555514016029 | Date3 Oct 2026 | 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- Withdrawn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
- Sanctuary™ ComfiTract Latex-Free Cheek Retractor
- Model / Reference
- Latex-Free Cheek Retractor, CR002-S63-P319
- Primary DI / UDI-DI
- 09555514016029
- Basic UDI-DI
- 955551401CCRSH01K5
- Direct Marketing DI
- 09555514016029
- EMDN Code
- Q010599 Dental instruments, single-use - other
- Device Class
- Class I
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- MY-MF-000002197
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Sanctuary Health Sdn Bhd
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