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X-ray barrier envelopes

by Premium Plus (Dongguan) Limited China EUDAMED

Ref PP198-2

EMDN Z11079085

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D125BRENVELOPENY Basic UDI-DIDate10 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dental X-Ray Barrier Envelopes
Model / Reference
PP198-2
Primary DI / UDI-DI
+D125ITLDPP19822
Basic UDI-DI
++D125BRENVELOPENY
Unit of Use DI
2
EMDN Code
Z11079085 Various x-ray film imaging support instruments - consumables
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000038259
Authorised representative
Premium Plus Poland sp. z o.o. PL-AR-000030110

Other devices from Premium Plus (Dongguan) Limited

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Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 6214ce71-cbab-43f4-9d17-ac4623d84d8f 61 fields · synced 22 Oct 2026