Identity
- Trade Name
- X-Ray Bite Cushions EUDAMED
- Device Name
- X-Ray Film Holders EUDAMED
- Model / Reference
- 2018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12520182 EUDAMED
- Basic UDI-DI
- ++D125FILMHOLDERKK EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Z11079085 VARIOUS X-RAY FILM IMAGING SUPPORT INSTRUMENTS - CONSUMABLES 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
X-Ray Bite Cushions 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 | ++D125FILMHOLDERKK | 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 (1)
- EUDAMED 14cdcc5d-e90f-4744-9e80-ba5b7d25046f 61 fields · synced Aug 2, 2026