Identity
- Device Name
- IMPRESSION TRAYS EUDAMED
- Model / Reference
- DIT1913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971241393142 EUDAMED
- Basic UDI-DI
- 697124139DIT0001DU EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Impression Trays by Tangshan Zhengtong Exhibition Co., Ltd. — 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 | 697124139DIT0001DU | Class I | Active |
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Manufacturer
- Manufacturer
- Tangshan Zhengtong Exhibition Co., Ltd.
- EUDAMED SRN
- CN-MF-000018452
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED ee5abe1c-844c-4dcf-aa5e-af46990b5e61 61 fields · synced Oct 6, 2026