Identity
- Trade Name
- Intraoral Tips EUDAMED
- Device Name
- Curved Tip Syringes EUDAMED
- Model / Reference
- 130004 EUDAMED086 EUDAMEDDXL740 EUDAMED130000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125BQ1300044 EUDAMED+D1250864 EUDAMED+D125BQDXL7404 EUDAMED+D125BQ1300004 EUDAMED
- Basic UDI-DI
- ++D125IMPRESSIONSYRINGENY EUDAMED
- Unit of Use DI
- 4 EUDAMED
- EMDN Code
- A020199 SYRINGES, 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
Intraoral Tips 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 | ++D125IMPRESSIONSYRINGENY | 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 (4)
- EUDAMED 08bf9e6b-53de-4a06-9d9b-6d76fa0649f4 61 fields · synced Jul 25, 2026
- EUDAMED 4b82acc0-6fa7-417e-8243-fd90af85f41e 61 fields · synced May 16, 2026
- EUDAMED 357a92af-9c52-4d82-a736-287bcc8e80d4 61 fields · synced May 17, 2026
- EUDAMED accea958-36e7-4709-9789-2991acf80eea 61 fields · synced May 18, 2026