← Back to catalogue
prophy cup
EUDAMEDClass I (EU MDR)
Ref 240604Model 240601/240602/240603/240604/240605/240606/240607/240608/240609/240610/240611/240612/240613/240614/240615/240616/240617/240618/240619/240620/240621/240622/240623/2406011/2406012/2406013/2406014/2406015/2406016/2406017/2406018/2406019/2406020
Identity
- Device Name
- prophy cup EUDAMED
- Model / Reference
- 240601/240602/240603/240604/240605/240606/240607/240608/240609/240610/240611/240612/240613/240614/240615/240616/240617/240618/240619/240620/240621/240622/240623/2406011/2406012/2406013/2406014/2406015/2406016/2406017/2406018/2406019/2406020 EUDAMED240604 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978429772645 EUDAMED
- Basic UDI-DI
- 697842977ZWPC4C EUDAMED
- EMDN Code
- Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Across Industrial Co., Ltd — Class I — 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 | 697842977ZWPC4C | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Across Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000047003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 75825979-a279-4509-917c-0fe4e8ed7c2d 61 fields · synced Jun 18, 2026