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Transform Tray Sample Pack (1x MU + 1x ML) - Dentate
EUDAMEDClass I (EU MDR)
Ref 118200
Identity
- Trade Name
- Transform Tray Sample Pack (1x MU + 1x ML) - Dentate EUDAMED
- Device Name
- Bite Trays EUDAMED
- Model / Reference
- 118200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840326415488 EUDAMED
- Basic UDI-DI
- 0843471116350D36733EHYDX EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Category: Dental impression tray, single-use
Transform Tray Sample Pack (1x MU + 1x ML) - Dentate by Young Innovations, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0843471116350D36733EHYDX | Class I | Active |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 8d7967ed-696a-49ba-88a9-48d4c529fa2b 61 fields · synced Jul 14, 2026