Identity
- Trade Name
- Etch Tips EUDAMED
- Device Name
- Luer-Lock Tips EUDAMED
- Model / Reference
- 305500 EUDAMED081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125BQ3055002 EUDAMED+D1250812 EUDAMED
- Basic UDI-DI
- ++D125LUERLOCKTIPNM 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
Etch 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 | ++D125LUERLOCKTIPNM | 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 931468b6-fc17-41d2-b073-d2319b063d38 61 fields · synced Aug 1, 2026
- EUDAMED c1dd0731-8e4b-4ad6-a71f-0733226442bb 61 fields · synced May 18, 2026