Identity
- Trade Name
- Impression Tray EUDAMED
- Device Name
- Impression Tray EUDAMED
- Model / Reference
- JI-IT-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003475307 EUDAMED
- Basic UDI-DI
- 08964003475IMPT119D EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Impression Tray by Jazbar International — 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 | 08964003475IMPT119D | Class I | Active |
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Manufacturer
- Manufacturer
- Jazbar International
- EUDAMED SRN
- PK-MF-000031447
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 4699754c-5474-493a-9103-c197bc06aa78 61 fields · synced Jul 30, 2026