Identity
- Trade Name
- Dental stone EUDAMED
- Device Name
- Dental stone EUDAMED
- Model / Reference
- 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977455000623 EUDAMED
- Basic UDI-DI
- 697745500zd9L EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Dental stone by Jingmen Tzu She Tang Gypsum 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 | 697745500zd9L | Class I | Active |
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Manufacturer
- Manufacturer
- Jingmen Tzu She Tang Gypsum Co., Ltd
- EUDAMED SRN
- CN-MF-000042911
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED b0ffa159-9457-4c12-8ed3-bb6963b9e587 61 fields · synced Jun 19, 2026