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Disposable Fluoride Foam Tray
EUDAMEDClass I (EU MDR)
Ref /Model DT01L,DT01M,DT01S,DT02L,DT02M,DT02S,DT03L,DT03M,DT03S
Identity
- Trade Name
- Disposable Fluoride Foam Tray EUDAMED
- Device Name
- Disposable Fluoride Foam Tray EUDAMED
- Model / Reference
- DT01L,DT01M,DT01S,DT02L,DT02M,DT02S,DT03L,DT03M,DT03S EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454003275 EUDAMED
- Basic UDI-DI
- 69544540DFFT001LM EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Disposable Fluoride Foam Tray by Huanghua Promisee Dental 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 | 69544540DFFT001LM | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4c2d2510-2e91-4ce6-a679-ab8bb36de123 61 fields · synced Jun 19, 2026