Identity
- Trade Name
- Disposable Mouth Mirrors EUDAMED
- Device Name
- Mouth Mirrors EUDAMED
- Model / Reference
- 850 EUDAMED800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1258502 EUDAMED+D1258002 EUDAMED
- Basic UDI-DI
- ++D125MOUTHMIRRORXV EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q010504 DENTISTRY MIRRORS AND STYLETS, 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
Disposable Mouth Mirrors 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 | ++D125MOUTHMIRRORXV | 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 (2)
- EUDAMED 9fa114e9-e3cd-4988-a4b7-fe64ef64fe57 61 fields · synced Oct 6, 2026
- EUDAMED 850beee3-3250-42cc-9c01-9810cf0da95d 61 fields · synced May 18, 2026