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Prophy cup
EUDAMEDClass IIa (EU MDR)
Ref 9010/30Ref 101360Ref 101361Ref 9005/30Ref 101358Ref 9008/30Ref 101359Ref 9010/120Ref 9007/30Ref 9005/120Ref 101365Ref 9002/30Ref 9003/30
Identity
- Trade Name
- Prophy cup EUDAMED
- Device Name
- Prophy cup EUDAMED
- Model / Reference
- 9010/30 EUDAMED101360 EUDAMED101361 EUDAMED9005/30 EUDAMED101358 EUDAMED9008/30 EUDAMED101359 EUDAMED9010/120 EUDAMED9007/30 EUDAMED9005/120 EUDAMED101365 EUDAMED9002/30 EUDAMED9003/30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973163112191 EUDAMED06973163111545 EUDAMED06973163111569 EUDAMED06973163112153 EUDAMED06973163111309 EUDAMED06973163112337 EUDAMED06973163111323 EUDAMED06973163112214 EUDAMED06973163112313 EUDAMED06973163112177 EUDAMED06973163111200 EUDAMED06973163112078 EUDAMED16973163110460 EUDAMED
- Basic UDI-DI
- 697316311DPA00006D7 EUDAMED697316311DPA00003CZ EUDAMED697316311DPA00005D5 EUDAMED
- EMDN Code
- Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Prophy cup by Suzhou Pac-Dent Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- Topex® Prophy Paste — Dentsply International · Class I
- Omni — Keystone Industries · Class I
- Disposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed — Premium Plus (Dongguan) Limited · Class IIa
- Dental City — ICP, INC. · Class I
- 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
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 | 697316311DPA00006D7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Pac-Dent Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021642
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (13)
- EUDAMED 8779bdf3-f902-47e8-8a39-e9b99db6126f 61 fields · synced Aug 1, 2026
- EUDAMED 0aea3fca-5151-466c-b5c7-3db6103a9f49 61 fields · synced May 16, 2026
- EUDAMED 53e417b2-d467-4d3c-b18f-753ea6e3800d 61 fields · synced May 16, 2026
- EUDAMED f88e8cbd-631d-4da6-9fc8-ce4eb9602af4 61 fields · synced May 16, 2026
- EUDAMED b6e6b78f-c0c6-40f8-b708-a005b5753a45 61 fields · synced May 17, 2026
- EUDAMED ce5fadde-c74e-4d80-ace9-a0091638f747 61 fields · synced May 18, 2026
- EUDAMED 276f34f9-455c-4c64-b930-7caee65704a5 61 fields · synced May 18, 2026
- EUDAMED d68eae91-9f46-4328-b0cd-b12e049f536d 61 fields · synced May 18, 2026
- EUDAMED bd645174-8f20-45fe-a9b6-e9337867a51f 61 fields · synced May 18, 2026
- EUDAMED fa8a9af3-1ab5-49b6-9385-7417da4b7c6f 61 fields · synced May 18, 2026
- EUDAMED 3102b6a9-cb9f-4cc0-afb3-f8cba460521f 61 fields · synced May 19, 2026
- EUDAMED 318a463f-b083-4f14-8374-4b74e69f2c1b 61 fields · synced May 19, 2026
- EUDAMED aacc1f11-f21c-4833-bd28-27d10731f36e 61 fields · synced May 19, 2026