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Sanctuary™
EUDAMEDClass I (EU MDR)
Ref DL512B-ECSH0Ref DA301G-EGSH0_DENTAL DAM BRINKER CLAMPS-B4Model DENTAL DAM FRAME, DENTAL DAM CLAMPS & WINGLESS CLAMPS, DENTAL DAM FORCEPS, DENTAL DAM PUNCH, DENTAL DAM PREMIUM KIT, CLAMPS WITH ORGANIZERRef DA010F-EGSH0_DENTAL DAM CLAMPS - RDC 207 (SANDBLAST)Ref DA011F-EGSH0_DENTAL DAM CLAMPS - RDC 2 (SANDBLAST)Ref DA008F-EGSH0_DENTAL DAM CLAMPS - RDC 203 (SANDBLAST)Ref DA005G-EGSH0Ref DA305G-EGSH0_DENTAL DAM WINGLESS CLAMPS-W56Ref DA304G-EGSH0_DENTAL DAM WINGLESS CLAMPS-W8ARef DA014F-EGSH0_DENTAL DAM CLAMPS - RDC 211 (SANDBLAST)
Identity
- Trade Name
- Sanctuary™ EUDAMED
- Device Name
- Sanctuary™ Latex Dental Dam EUDAMEDDENTAL DAM ACCESSORIES EUDAMED
- Model / Reference
- DL512B-ECSH0 EUDAMEDDENTAL DAM FRAME, DENTAL DAM CLAMPS & WINGLESS CLAMPS, DENTAL DAM FORCEPS, DENTAL DAM PUNCH, DENTAL DAM PREMIUM KIT, CLAMPS WITH ORGANIZER EUDAMEDDA301G-EGSH0_DENTAL DAM BRINKER CLAMPS-B4 EUDAMEDDA010F-EGSH0_DENTAL DAM CLAMPS - RDC 207 (SANDBLAST) EUDAMEDDA011F-EGSH0_DENTAL DAM CLAMPS - RDC 2 (SANDBLAST) EUDAMEDDA008F-EGSH0_DENTAL DAM CLAMPS - RDC 203 (SANDBLAST) EUDAMEDDA005G-EGSH0 EUDAMEDDA305G-EGSH0_DENTAL DAM WINGLESS CLAMPS-W56 EUDAMEDDA304G-EGSH0_DENTAL DAM WINGLESS CLAMPS-W8A EUDAMEDDA014F-EGSH0_DENTAL DAM CLAMPS - RDC 211 (SANDBLAST) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555514007515 EUDAMED09555514011161 EUDAMED09555514009274 EUDAMED09555514009281 EUDAMED09555514009250 EUDAMED09555514009205 EUDAMED09555514011208 EUDAMED09555514011192 EUDAMED09555514009311 EUDAMED
- Basic UDI-DI
- 955551400LDDSH01JW EUDAMED955551400DDASH01DM EUDAMED
- Direct Marketing DI
- 09555514007515 EUDAMED09555514011161 EUDAMED09555514009274 EUDAMED09555514009281 EUDAMED09555514009250 EUDAMED09555514009205 EUDAMED09555514011208 EUDAMED09555514011192 EUDAMED09555514009311 EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMEDQ010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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 | 955551400LDDSH01JW | 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 (9)
- EUDAMED 0a3bc3e2-923f-4288-8f2e-d9cfe269613c 61 fields · synced Jul 25, 2026
- EUDAMED bffc37b3-8a97-4cb5-869c-db1e7527a57a 61 fields · synced May 17, 2026
- EUDAMED 4fabe1a8-cf5e-4656-a7a7-e26594836f0b 61 fields · synced May 17, 2026
- EUDAMED d208df63-43b6-4d95-8c25-982c1e7ed6ed 61 fields · synced May 17, 2026
- EUDAMED 55a9a789-ffdc-423d-ac3c-73a11b8a344e 61 fields · synced May 18, 2026
- EUDAMED 4e9aa03a-f517-4e74-9a12-907b6b53f354 61 fields · synced May 18, 2026
- EUDAMED 8c678a2c-7948-46d9-93d3-627a68bf2e58 61 fields · synced May 18, 2026
- EUDAMED 40c67c6e-1af4-4496-84cb-e74845834d1a 61 fields · synced Jul 9, 2026
- EUDAMED 68a63e8e-133c-4ee2-b7c7-d94f9e968611 61 fields · synced Jul 21, 2026