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Disposable Prophy Cups, Screw-In, Turbine Blades Short
EUDAMEDClass IIa (EU MDR)
Ref T-S221GRRef T-S221YLRef T-S221PKRef T-S221RARef T-S221LMRef T-S221DBRef T-S221RDRef T-S221LV
Identity
- Trade Name
- Disposable Prophy Cups, Screw-In, Turbine Blades Short EUDAMED
- Device Name
- Dental Prophy Cups EUDAMED
- Model / Reference
- T-S221GR EUDAMEDT-S221YL EUDAMEDT-S221PK EUDAMEDT-S221RA EUDAMEDT-S221LM EUDAMEDT-S221DB EUDAMEDT-S221RD EUDAMEDT-S221LV EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125TS221GR2 EUDAMED+D125TS221YL2 EUDAMED+D125TS221PK2 EUDAMED+D125TS221RA2 EUDAMED+D125TS221LM2 EUDAMED+D125TS221DB2 EUDAMED+D125TS221RD2 EUDAMED+D125TS221LV2 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
Category: Dentifrice
Disposable Prophy Cups, Screw-In, Turbine Blades Short by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
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- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · Class I
- Omni — Keystone Industries · Class I
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 | ++D125PROPHYCUPSBS | Class IIa | 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 (8)
- EUDAMED 242920a6-d13d-4705-b534-4498c878f8e0 61 fields · synced Aug 1, 2026
- EUDAMED 424967d1-8efe-4a9a-989d-43c20af9962c 61 fields · synced May 17, 2026
- EUDAMED 7af6a16a-0015-4b4a-a260-c5ddd5d31151 61 fields · synced May 17, 2026
- EUDAMED bd3ae854-e023-42e7-a1f0-d6eb27e0ca65 61 fields · synced May 18, 2026
- EUDAMED b084a4bb-4d00-4676-bf4e-34f08e02ad6d 61 fields · synced May 18, 2026
- EUDAMED 5725157f-eb4d-4f81-9528-37df8ae5935e 61 fields · synced May 18, 2026
- EUDAMED 966fdb68-c773-43af-ad2b-704a81d6b4f9 61 fields · synced May 19, 2026
- EUDAMED c7dd02ce-3dde-4b8e-9477-a82f39cc13af 61 fields · synced May 19, 2026