Identity
- Trade Name
- Air-water syringe tip EUDAMED
- Device Name
- Dental Syringe Tips EUDAMED
- Model / Reference
- PD002112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125FIPD0021122 EUDAMED
- Basic UDI-DI
- ++D125SYRINGETIPS4Q EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Air-water syringe tip by Premium Plus (Dongguan) Limited — Class IIa — 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 | ++D125SYRINGETIPS4Q | Class IIa | 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 (1)
- EUDAMED a8837bb6-e5f9-4751-92b9-b89405c04f2e 61 fields · synced Jul 14, 2026