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Mouth Tray
EUDAMEDClass I (EU MDR)
Ref MT-5Model MT-1,MT-2,MT-3,MT-4,MT-5,MT-6,MT-7
Identity
- Device Name
- Mouth Tray EUDAMED
- Model / Reference
- MT-1,MT-2,MT-3,MT-4,MT-5,MT-6,MT-7 EUDAMEDMT-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970016620254 EUDAMED
- Basic UDI-DI
- 697001662MouthTrayZ8 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Mouth Tray by Jiangxi Dentalbright Technology 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 | 697001662MouthTrayZ8 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangxi Dentalbright Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000009767
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d0f508c6-fea2-410d-a406-a3bc4f130a00 61 fields · synced Jun 18, 2026