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X-ray barrier envelopes
EUDAMEDClass I (EU MDR)
Ref PP198-0Ref PP198-1Ref PP198-2
Identity
- Trade Name
- X-ray barrier envelopes EUDAMED
- Device Name
- Dental X-Ray Barrier Envelopes EUDAMED
- Model / Reference
- PP198-0 EUDAMEDPP198-1 EUDAMEDPP198-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125ITLDPP19802 EUDAMED+D125ITLDPP19812 EUDAMED+D125ITLDPP19822 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
X-ray barrier envelopes 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 (3)
- EUDAMED d5338351-4d1e-4b49-996c-8fdc23c851a5 61 fields · synced Oct 6, 2026
- EUDAMED c4292893-08b0-4879-9034-699091f73db5 61 fields · synced May 17, 2026
- EUDAMED 6214ce71-cbab-43f4-9d17-ac4623d84d8f 61 fields · synced May 18, 2026