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Brush Applicators
EUDAMEDClass I (EU MDR)
Ref 7500LRef 7500YRef 7510GRef 7501LRef 7510B
Identity
- Trade Name
- Brush Applicators EUDAMED
- Device Name
- Applicators EUDAMED
- Model / Reference
- 7500L EUDAMED7500Y EUDAMED7510G EUDAMED7501L EUDAMED7510B EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1257500L2 EUDAMED+D1257500Y2 EUDAMED+D1257510G2 EUDAMED+D1257501L2 EUDAMED+D1257510B2 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 by Premium Plus (Dongguan) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental material injection cannula, 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 | ++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 (5)
- EUDAMED 8efe57e6-caac-4963-a983-1f6b87eb8c71 61 fields · synced Jul 20, 2026
- EUDAMED 752da5a9-1982-48da-be77-67367d230f20 61 fields · synced May 17, 2026
- EUDAMED 73229405-55cf-4250-a71d-11c54ea5e2bb 61 fields · synced May 18, 2026
- EUDAMED 70fa8c23-3508-4f3f-be0c-5bc272de46ab 61 fields · synced May 18, 2026
- EUDAMED b9188632-09f9-44bb-87e0-b995daedc5b2 61 fields · synced May 19, 2026