Identity
- Trade Name
- Applicators EUDAMED
- Device Name
- Applicators EUDAMED
- Model / Reference
- 534 EUDAMED535 EUDAMED1626 EUDAMED1625 EUDAMED1624 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125PTDM5342 EUDAMED+D125PTDM5352 EUDAMED+D125HRVK16262 EUDAMED+D125HRVK16252 EUDAMED+D125HRVK16242 EUDAMED
- Basic UDI-DI
- ++D125APPLICATORK8 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
Applicators 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 | ++D125APPLICATORK8 | 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 (5)
- EUDAMED fc4d7a6d-4c94-4eda-96d7-0ff7cc4b1285 61 fields · synced Jul 25, 2026
- EUDAMED 9de86318-8a7f-4676-8fe8-e50f5d90e817 61 fields · synced May 18, 2026
- EUDAMED e6e6ccdf-e323-40e1-99ca-6bfc8ed93492 61 fields · synced May 18, 2026
- EUDAMED 49a166d9-9bd4-49c8-a063-56decc6ff010 61 fields · synced May 18, 2026
- EUDAMED 4bc44d9e-de73-424a-9946-dcae24b60837 61 fields · synced May 19, 2026