Identity
- Trade Name
- Brush Applicators Tips EUDAMED
- Device Name
- Applicators EUDAMED
- Model / Reference
- 7511L EUDAMED7511Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1257511L2 EUDAMED+D1257511Y2 EUDAMED
- Basic UDI-DI
- ++D125APPLICATORK8 EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE 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
Category: Dental material injection cannula, single-use
Brush Applicators Tips by Premium Plus (Dongguan) Limited — 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 | ++D125APPLICATORK8 | 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 (2)
- EUDAMED 94a647ea-f869-4570-bfa9-37b492d383c0 61 fields · synced Jul 16, 2026
- EUDAMED e98415ff-9c26-48e4-831c-266d261ff34c 61 fields · synced May 18, 2026