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dental splint
EUDAMEDClass I (EU MDR)
Ref 240410Model 240401/240402/240403/240404/240405/240406/240407/240408/240409/240410/240411/240412/240413/240414/240415
Identity
- Device Name
- dental splint EUDAMED
- Model / Reference
- 240401/240402/240403/240404/240405/240406/240407/240408/240409/240410/240411/240412/240413/240414/240415 EUDAMED240410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978429771945 EUDAMED
- Basic UDI-DI
- 697842977ZWDS48 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL 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
dental splint by Across Industrial 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 | 697842977ZWDS48 | Class I | Active |
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Manufacturer
- Manufacturer
- Across Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000047003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e591dc2f-932f-4322-ab43-65f7ac592207 61 fields · synced Jun 19, 2026