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Disposable Prophy Cups, CA Metal Shank, Ribbed & Webbed Short
EUDAMEDClass IIa (EU MDR)
Ref S222ORRef S222RDRef S222GRRef PD003021Ref S222RARef S222SARef S222XA
Identity
- Trade Name
- Disposable Prophy Cups, CA Metal Shank, Ribbed & Webbed Short EUDAMED
- Device Name
- Dental Prophy Cups EUDAMED
- Model / Reference
- S222OR EUDAMEDS222RD EUDAMEDS222GR EUDAMEDPD003021 EUDAMEDS222RA EUDAMEDS222SA EUDAMEDS222XA EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125S222OR2 EUDAMED+D125S222RD2 EUDAMED+D125S222GR2 EUDAMED+D125FIPD0030212 EUDAMED+D125S222RA2 EUDAMED+D125S222SA2 EUDAMED+D125S222XA2 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, CA Metal Shank, Ribbed & Webbed Short by Premium Plus (Dongguan) Limited — Class IIa — MDR — listed in EUDAMED
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Also classified as Dentifrice.
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- 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 (7)
- EUDAMED 2784ba69-ec5e-4335-943e-a9ae996b97d1 61 fields · synced Jul 31, 2026
- EUDAMED a189ce3e-6b6b-490b-9770-0e09459fdb94 61 fields · synced May 11, 2026
- EUDAMED 8b2d26f3-ff23-4d42-93e4-93736674ed22 61 fields · synced May 17, 2026
- EUDAMED 6b41b005-bd2e-483a-b824-b5054f1e0929 61 fields · synced May 17, 2026
- EUDAMED 29c082f3-047f-46e3-a280-3b91f8eff3bc 61 fields · synced May 18, 2026
- EUDAMED e2218906-e1b1-4d82-8c8a-b4f991458b0d 61 fields · synced May 18, 2026
- EUDAMED 5dc0c156-e617-48ec-9794-f2acea387805 61 fields · synced May 18, 2026