← Back to catalogue
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
- 06975652007988 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
Category: Dental impression tray, single-use
Fluoride Foam Trays by Hubei Guarddent Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
- Miratray Partiell PR 100er — Hager & Werken GmbH & Co. KG · Class I
- COE® — Gc America Inc. · Class I
- Plasdent — PLASDENT CORP. · Class I
- EXCELLENT — PLASDENT CORP. · Class I
- IMPRESSION TRAYS PERFORATED FULL DENTURE UPPER XL U4 — Daddy D Pro · Class I
- Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Zap Dual Arch Flouride Gel Trays — CROSSTEX INTERNATIONAL, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hubei Guarddent Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028116
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED b5a1f913-80fd-40e4-b36e-47093df96b97 61 fields · synced Jun 18, 2026