Identity
- Trade Name
- Disposable Saliva Ejectors Soft Tip EUDAMED
- Device Name
- Dental Saliva Ejectors EUDAMED
- Model / Reference
- 333BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125333BC4 EUDAMED
- Basic UDI-DI
- ++D125SALIVAEJECTORSYW EUDAMED
- Unit of Use DI
- 4 EUDAMED
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS 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
Disposable Saliva Ejectors Soft 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 | ++D125SALIVAEJECTORSYW | 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 5da59c37-f5df-477f-a7ee-3d15d2936f35 61 fields · synced Jul 22, 2026