Identity
- Trade Name
- Prophy Cups EUDAMED
- Device Name
- Prophy Cups EUDAMED
- Model / Reference
- PC-330 EUDAMEDPC-310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979999943114 EUDAMED06979999943220 EUDAMED
- Basic UDI-DI
- 697999994Prophycup311NL EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Prophy Cups by Snowdent Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697999994Prophycup311NL | Class I | Active |
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Manufacturer
- Manufacturer
- Snowdent Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000008775
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ace237d3-c903-4919-8645-7c728b48a5ca 61 fields · synced Jul 24, 2026
- EUDAMED 4406f4bd-13ff-4f42-8404-4cf33641995e 61 fields · synced May 18, 2026