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X-Ray Sensor Sleeves/ Mouth Mirror Sleeves

EUDAMED

Class I (EU MDR)

Ref 140XSRef 140MRef 140LRef 140S

by Premium Plus (Dongguan) Limited

Identity

Trade Name
X-Ray Sensor Sleeves/ Mouth Mirror Sleeves EUDAMED
Device Name
Barrier Sleeves EUDAMED
Model / Reference
140XS EUDAMED
140M EUDAMED
140L EUDAMED
140S EUDAMED

Identifiers

Primary DI / UDI-DI
+D125140XS2 EUDAMED
+D125140M2 EUDAMED
+D125140L2 EUDAMED
+D125140S2 EUDAMED
Basic UDI-DI
++D125BRSLEEVE2W EUDAMED
Unit of Use DI
2 EUDAMED
EMDN Code
T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER 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 Sensor Sleeves/ Mouth Mirror Sleeves 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

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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 (4)

  • EUDAMED 6a4aadcf-3dea-4ed4-9a4f-877a2bd355bf 61 fields · synced Jul 16, 2026
  • EUDAMED 8499367c-079c-4cba-9d37-efc4af3e40c7 61 fields · synced May 16, 2026
  • EUDAMED ddefd76f-03e6-42a2-843b-01d6c158f7e8 61 fields · synced May 17, 2026
  • EUDAMED c7cd5fbc-97f4-429d-a1b8-20793349b701 61 fields · synced May 17, 2026