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Fluoride Foam Trays
EUDAMEDClass I (EU MDR)
Ref Dual ArchModel Dual Arch:GD-1541、GD-1542、GD-1543、GD-1544、GD-1544G、GD-1541T、GD-1542T、GD-1543T；Single：GD-1545、GD-1546、GD-1547、GD-1548、GD-1548G
Identity
- Trade Name
- FLUORIDE FOAM TRAYS EUDAMED
- Model / Reference
- Dual Arch:GD-1541、GD-1542、GD-1543、GD-1544、GD-1544G、GD-1541T、GD-1542T、GD-1543T；Single：GD-1545、GD-1546、GD-1547、GD-1548、GD-1548G EUDAMEDDual Arch EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975652008022 EUDAMED06975652008107 EUDAMED06975652008152 EUDAMED06975652007940 EUDAMED06975652008190 EUDAMED06975652007872 EUDAMED06975652008015 EUDAMED
- Basic UDI-DI
- 697565200FFT001ER EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Fluoride Foam Trays by Hubei Guarddent Medical 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 | 697565200FFT001ER | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Guarddent Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028116
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (7)
- EUDAMED 27488c6a-1a24-4bc7-a1ee-7007eb8550ea 61 fields · synced Oct 8, 2026
- EUDAMED 8a5dd514-285e-4be6-b0cc-3a1175be1611 61 fields · synced May 17, 2026
- EUDAMED 4ed9a298-9d40-459b-8ffd-5c157500a444 61 fields · synced May 19, 2026
- EUDAMED 0145f28d-1030-4c14-a651-3876888b474a 61 fields · synced May 19, 2026
- EUDAMED af40cc8d-16c4-4d78-ba83-d9f3bc89870b 61 fields · synced May 19, 2026
- EUDAMED 66b7938d-4c3a-45fa-ae7a-6a535f9d35b5 61 fields · synced May 19, 2026
- EUDAMED a7f2262c-c291-4820-ad63-0adc7fbccf60 61 fields · synced May 19, 2026