← Back to catalogue
ComfiTract Latex Free Cheek Retractor 85mm (Large)
EUDAMEDClass I (EU MDR)
Ref CR001-S63-P319Model Latex-Free Cheek RetractorRef CR001-S63-P320
Identity
- Trade Name
- ComfiTract Latex Free Cheek Retractor 85mm (Large) EUDAMED
- Device Name
- Sanctuary™ ComfiTract Latex-Free Cheek Retractor EUDAMED
- Model / Reference
- Latex-Free Cheek Retractor EUDAMEDCR001-S63-P319 EUDAMEDCR001-S63-P320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555514016012 EUDAMED09555514016685 EUDAMED
- Basic UDI-DI
- 955551401CCRSH01K5 EUDAMED
- Unit of Use DI
- 09555514016708 EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ComfiTract Latex Free Cheek Retractor 85mm (Large) by Sanctuary Health Sdn Bhd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955551401CCRSH01K5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sanctuary Health Sdn Bhd
- EUDAMED SRN
- MY-MF-000002197
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 9eb00d15-d559-4a8d-bf49-1057bf5968bc 61 fields · synced Jul 24, 2026
- EUDAMED a2b65ae1-55d0-4ad7-b60b-c51e393f5439 61 fields · synced May 17, 2026