Identity
- Trade Name
- SR Triplex Cold Standard Kit 36P-V EUDAMED
- Device Name
- ProBase Hot / ProBase Cold, SR Triplex Cold EUDAMED
- Model / Reference
- 547062AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07615208302332 EUDAMED
- Basic UDI-DI
- 76152082APROS001VT EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Liechtenstein 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
SR Triplex Cold Standard Kit 36P-V by Ivoclar Vivadent AG — Class IIa — 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 | 76152082APROS001VT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (1)
- EUDAMED 4f852e19-a447-4558-88a9-807cec92d115 61 fields · synced Jul 22, 2026