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Sanctuary™
EUDAMEDClass I (EU MDR)
Ref DA004F-EGSH0_DENTAL DAM CLAMPS WITH ORGANIZERModel DENTAL DAM FRAME, DENTAL DAM CLAMPS & WINGLESS CLAMPS, DENTAL DAM FORCEPS, DENTAL DAM PUNCH, DENTAL DAM PREMIUM KIT, CLAMPS WITH ORGANIZER
Identity
- Trade Name
- Sanctuary™ EUDAMED
- Device Name
- DENTAL DAM ACCESSORIES EUDAMED
- Model / Reference
- DENTAL DAM FRAME, DENTAL DAM CLAMPS & WINGLESS CLAMPS, DENTAL DAM FORCEPS, DENTAL DAM PUNCH, DENTAL DAM PREMIUM KIT, CLAMPS WITH ORGANIZER EUDAMEDDA004F-EGSH0_DENTAL DAM CLAMPS WITH ORGANIZER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555514009229 EUDAMED
- Basic UDI-DI
- 955551400DDASH01DM EUDAMED
- Direct Marketing DI
- 09555514009229 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Sanctuary™ 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 | 955551400DDASH01DM | 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 (1)
- EUDAMED 0e200159-95ab-4135-83c3-af50c80c89b0 61 fields · synced May 23, 2026