Identity
- Trade Name
- PSP Protective Paper Covers EUDAMED
- Device Name
- Dental X-Ray Barrier Envelopes EUDAMED
- Model / Reference
- 178-2 EUDAMED178-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12517822 EUDAMED+D12517802 EUDAMED
- Basic UDI-DI
- ++D125BRENVELOPENY 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
PSP Protective Paper Covers 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 | ++D125BRENVELOPENY | 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 70183f7f-6f2b-403e-904a-454c29dcf004 61 fields · synced Jul 30, 2026
- EUDAMED 5a3e02f2-3c72-4533-a653-590bb5fb4c7c 61 fields · synced May 18, 2026