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Disposable Prophy Cups, Screw-In, Turbine Blades

EUDAMED

Class IIa (EU MDR)

Ref T-221LVRef T-221ORRef 658 300 036 500 060Ref T-221XARef T-221YLRef T-221PKRef T-221RDRef T-221DB

by Premium Plus (Dongguan) Limited

Identity

Trade Name
Disposable Prophy Cups, Screw-In, Turbine Blades EUDAMED
Device Name
Dental Prophy Cups EUDAMED
Model / Reference
T-221LV EUDAMED
T-221OR EUDAMED
658 300 036 500 060 EUDAMED
T-221XA EUDAMED
T-221YL EUDAMED
T-221PK EUDAMED
T-221RD EUDAMED
T-221DB EUDAMED

Identifiers

Primary DI / UDI-DI
+D125T221LV2 EUDAMED
+D125T221OR2 EUDAMED
+D1256583000365000602 EUDAMED
+D125T221XA2 EUDAMED
+D125T221YL2 EUDAMED
+D125T221PK2 EUDAMED
+D125T221RD2 EUDAMED
+D125T221DB2 EUDAMED
Basic UDI-DI
++D125PROPHYCUPSBS EUDAMED
Unit of Use DI
2 EUDAMED
EMDN Code
Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa 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

Disposable Prophy Cups, Screw-In, Turbine Blades by Premium Plus (Dongguan) Limited — Class IIa — 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

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

Sources (8)

  • EUDAMED 24963b90-41fe-493b-a531-02ba14d34aec 61 fields · synced Sep 17, 2026
  • EUDAMED 9ef028f7-f675-4a86-b545-95dfae93c983 61 fields · synced May 17, 2026
  • EUDAMED 768e7d00-ba4f-450f-aa63-daa26633059c 61 fields · synced May 17, 2026
  • EUDAMED 80580f00-95c8-4a7c-9c29-c0aeb06ea4af 61 fields · synced May 17, 2026
  • EUDAMED 8be4850a-1c9d-4258-b7aa-59cc8ceaf9b0 61 fields · synced May 18, 2026
  • EUDAMED b9c76875-6b1c-4573-8f47-80e169925a4a 61 fields · synced May 18, 2026
  • EUDAMED 7f2f59f3-c655-4657-9f48-a3255f166629 61 fields · synced May 18, 2026
  • EUDAMED 60573079-74d4-445c-975c-dc7d8b1fa651 61 fields · synced May 18, 2026