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Disposable Soft Touch Oral Evacuators Vented Slotted
EUDAMEDClass IIa (EU MDR)
Ref ST001BLUE
Identity
- Trade Name
- Disposable Soft Touch Oral Evacuators Vented Slotted EUDAMED
- Device Name
- Dental Suction Tips EUDAMED
- Model / Reference
- ST001BLUE EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125ST001BLUE4 EUDAMED
- Basic UDI-DI
- ++D125SUCTIONTIPSYF 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 Soft Touch Oral Evacuators Vented Slotted 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 | ++D125SUCTIONTIPSYF | 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 b4e8e293-580a-4365-ab99-56c5f0a88364 61 fields · synced Jun 19, 2026