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PSP Barrier Envelopes
EUDAMEDClass I (EU MDR)
Ref 198-2Ref 198-1Ref 188-0Ref 188-3Ref 199-0Ref 188-1Ref 199-1Ref 188-2Ref 188-4Ref 199-2Ref 198-2B
Identity
- Trade Name
- PSP Barrier Envelopes EUDAMED
- Device Name
- Dental X-Ray Barrier Envelopes EUDAMED
- Model / Reference
- 198-2 EUDAMED198-1 EUDAMED188-0 EUDAMED188-3 EUDAMED199-0 EUDAMED188-1 EUDAMED199-1 EUDAMED188-2 EUDAMED188-4 EUDAMED199-2 EUDAMED198-2B EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12519822 EUDAMED+D12519812 EUDAMED+D12518802 EUDAMED+D12518832 EUDAMED+D12519902 EUDAMED+D12518812 EUDAMED+D12519912 EUDAMED+D12518822 EUDAMED+D12518842 EUDAMED+D12519922 EUDAMED+D1251982B2 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 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 (11)
- EUDAMED 31653125-8dc4-478a-81dd-772515ce6362 61 fields · synced Aug 2, 2026
- EUDAMED 4d410a74-2c68-481f-9c83-6a9dd086ee4e 61 fields · synced May 16, 2026
- EUDAMED 37d8f470-bb43-4a43-aa9f-d0fbe38c85da 61 fields · synced May 16, 2026
- EUDAMED ff17a247-f1ec-469d-ae71-1cfd9e677b0e 61 fields · synced May 17, 2026
- EUDAMED 737c6d07-bba7-4c14-a1b8-109dfa89e6b0 61 fields · synced May 17, 2026
- EUDAMED 491b83e3-dbf8-4984-8f72-56e83adc56e0 61 fields · synced May 17, 2026
- EUDAMED d385f860-6600-4179-88d6-752e9ee0224b 61 fields · synced May 17, 2026
- EUDAMED 869e19fb-e4ef-45f5-ae8c-b8b511e373f7 61 fields · synced May 18, 2026
- EUDAMED d0e33179-b7e5-4c60-8ad0-588c998c5391 61 fields · synced May 18, 2026
- EUDAMED 03b44bf2-43f8-450d-88d9-0b102657b92c 61 fields · synced May 19, 2026
- EUDAMED 2c89a98d-1c54-4bda-b3d5-b883fbff7c8d 61 fields · synced May 19, 2026