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Mouth Guard
EUDAMEDClass I (EU MDR)
Ref TW-T013Model 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 customizedRef TW-T016Ref TW-T020Ref TW-T012Ref TW-T008Ref TW-T004Ref TW-T005Ref TW-T003Ref TW-T010Ref TW-T001
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-T013 EUDAMEDTW-T016 EUDAMEDTW-T020 EUDAMEDTW-T012 EUDAMEDTW-T008 EUDAMEDTW-T004 EUDAMEDTW-T005 EUDAMEDTW-T003 EUDAMEDTW-T010 EUDAMEDTW-T001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939797200130 EUDAMED06939797200161 EUDAMED06939797200208 EUDAMED06939797200123 EUDAMED06939797200086 EUDAMED06939797200048 EUDAMED06939797200055 EUDAMED06939797200031 EUDAMED06939797200109 EUDAMED06939797200017 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 EUDAMEDNorway EUDAMEDDenmark EUDAMEDItaly EUDAMEDFinland EUDAMEDFrance EUDAMEDAustria 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 (10)
- EUDAMED fe963a3a-4774-43d2-8681-552afed8c4f3 61 fields · synced Jul 27, 2026
- EUDAMED 53558fe5-5ac9-4b09-ae3f-032d93eb729c 61 fields · synced May 17, 2026
- EUDAMED 53021ff7-6e25-4393-bf9b-f509f87e6b5a 61 fields · synced May 17, 2026
- EUDAMED b91cd610-c1a5-4283-a4bb-8c36b428e6b6 61 fields · synced May 17, 2026
- EUDAMED ca06d9c9-d4d0-4989-8466-a843bbce9428 61 fields · synced May 18, 2026
- EUDAMED 2ae42daa-e4b5-474a-a3d1-2f40e4b6db07 61 fields · synced May 18, 2026
- EUDAMED 11b2467b-a862-4a25-8fbc-78fadebfcd51 61 fields · synced May 18, 2026
- EUDAMED 7d65675a-8bbb-46dd-b019-f02582623f7d 61 fields · synced May 19, 2026
- EUDAMED ad5826dd-f5aa-4771-bfdd-d2d4289d766b 61 fields · synced May 19, 2026
- EUDAMED a9276ed4-7ad4-4398-9ed5-1eeb3d3a3eec 61 fields · synced May 19, 2026