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Mouth Guard
EUDAMEDClass I (EU MDR)
Ref TW-T018Model TW-T001，TW-T002，TW-T003，TW-T004，TW-T005，TW-T006，TW-T007，TW-T008，TW-T009，TW-T010，TW-T011，TW-T012，TW-T013，TW-T014，TW-T015，TW-T016，TW-T017，TW-T018，TW-T019，TW-T020，or customized
Identity
- Device Name
- Mouth Guard EUDAMED
- Model / Reference
- TW-T001，TW-T002，TW-T003，TW-T004，TW-T005，TW-T006，TW-T007，TW-T008，TW-T009，TW-T010，TW-T011，TW-T012，TW-T013，TW-T014，TW-T015，TW-T016，TW-T017，TW-T018，TW-T019，TW-T020，or customized EUDAMEDTW-T018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939797200185 EUDAMED
- Basic UDI-DI
- 69397972MG001VN EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Category: Dental impression tray, single-use
Mouth Guard by Fuzhou Delphin Bio-tech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental impression tray, single-use.
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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 | 69397972MG001VN | Class I | Active |
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Manufacturer
- Manufacturer
- Fuzhou Delphin Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000050306
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e616d57e-6060-411b-b075-b8be906b1faf 61 fields · synced Jun 19, 2026