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ComfiTract Latex Free Cheek Retractor 75mm (Medium)
EUDAMEDClass I (EU MDR)
Ref CR002-S63-P320Model Latex-Free Cheek RetractorRef CR002-S63-P319
Identity
- Trade Name
- ComfiTract Latex Free Cheek Retractor 75mm (Medium) EUDAMEDComfiTract Latex Free Cheek Retractor 75mm (Medium EUDAMED
- Device Name
- Sanctuary™ ComfiTract Latex-Free Cheek Retractor EUDAMED
- Model / Reference
- Latex-Free Cheek Retractor EUDAMEDCR002-S63-P320 EUDAMEDCR002-S63-P319 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555514016692 EUDAMED09555514016029 EUDAMED
- Basic UDI-DI
- 955551401CCRSH01K5 EUDAMED
- Unit of Use DI
- 09555514016715 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 75mm (Medium) 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 |
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Manufacturer
- Manufacturer
- Sanctuary Health Sdn Bhd
- EUDAMED SRN
- MY-MF-000002197
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 24cffdb6-0faa-4a8f-a4b0-19b5a2764353 61 fields · synced Jul 14, 2026
- EUDAMED 4de71d5c-c4fe-4db5-9bd0-5779ecff692d 61 fields · synced May 17, 2026