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Disposable Fluoride Foam Tray
EUDAMEDClass I (EU MDR)
Ref /Model DT01L,DT01M,DT01S,DT02L,DT02M,DT02S,DT03L,DT03M,DT03SRef DT01SRef DT01L
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/ EUDAMEDDT01S EUDAMEDDT01L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454000151 EUDAMED06954454000168 EUDAMED06954454000175 EUDAMED06954454006566 EUDAMED
- Basic UDI-DI
- 69544540DFFT001LM EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMEDGreece EUDAMEDGermany EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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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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 (6)
- EUDAMED af801540-b58b-476b-b7f3-59aba9883547 61 fields · synced Oct 9, 2026
- EUDAMED 5fca0936-5b45-4f7b-8b67-1af478320555 61 fields · synced May 18, 2026
- EUDAMED ec6ce4d5-d651-4f4a-b646-20bb288722bf 61 fields · synced May 18, 2026
- EUDAMED 8763e33e-d87e-41a9-aab3-2c8b1402f3fe 61 fields · synced May 18, 2026
- EUDAMED 8ff12636-0fb4-472e-907d-19e227e65967 61 fields · synced Oct 7, 2026
- EUDAMED 1b5b5948-2bc9-4da6-b5dc-a3cea39929df 61 fields · synced Oct 9, 2026