Identity
- Trade Name
- Roeko Abrasive Strip EUDAMED
- Device Name
- Roeko Polishing / Abrasive strip EUDAMED
- Model / Reference
- 560040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E2995600400 EUDAMED
- Basic UDI-DI
- ++E299ROEKOPOLISHABRASIX6 EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I 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
Roeko Abrasive Strip by Polydentia SA — 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 | ++E299ROEKOPOLISHABRASIX6 | Class I | Active |
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Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-MF-000008779
- Authorised Representative
- IDD International Dental Distributors AG LI-AR-000008367
Sources (1)
- EUDAMED 5a356082-656a-4d9c-afea-ba99c6d5f068 61 fields · synced Jun 17, 2026