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Fluoride Trays
EUDAMEDClass I (EU MDR)
Ref PP-622Ref 7800LRef 7801LRef 7800SRef PP-621Ref PP-620
Identity
- Trade Name
- Fluoride Trays EUDAMED
- Device Name
- Fluoride Trays EUDAMED
- Model / Reference
- PP-622 EUDAMED7800L EUDAMED7801L EUDAMED7800S EUDAMEDPP-621 EUDAMEDPP-620 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125ITLDPP6222 EUDAMED+D1257800L2 EUDAMED+D1257801L2 EUDAMED+D1257800S2 EUDAMED+D125ITLDPP6212 EUDAMED+D125ITLDPP6202 EUDAMED
- Basic UDI-DI
- ++D125FLUORIDETRAYEC EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Trays by Premium Plus (Dongguan) Limited — 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 | ++D125FLUORIDETRAYEC | Class I | Active |
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Manufacturer
- Manufacturer
- Premium Plus (Dongguan) Limited
- EUDAMED SRN
- CN-MF-000038259
- Authorised Representative
- Premium Plus Poland sp. z o.o. PL-AR-000030110
Sources (6)
- EUDAMED 3b732340-a96e-40d8-81fe-95532fb20772 61 fields · synced Aug 2, 2026
- EUDAMED c9bac2d9-ac80-434a-becd-b8698d35b453 61 fields · synced May 16, 2026
- EUDAMED 5ff3f3e3-2b43-4019-bcb5-cb5deeee2d3e 61 fields · synced May 18, 2026
- EUDAMED e5a143df-50a1-4770-ada9-2017a36897d3 61 fields · synced May 18, 2026
- EUDAMED b1e67fc4-bf97-4aa4-98ba-9177c065c6c5 61 fields · synced May 18, 2026
- EUDAMED f45886ec-a0bc-4c5e-b26b-88ea1d4fcfa6 61 fields · synced May 18, 2026