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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
- 06975652008091 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 (1)
- EUDAMED 9bd7fbeb-9132-49c8-a354-559f38be9ccf 61 fields · synced Jun 18, 2026