Identity
- Trade Name
- Roeko Steel matrix band soft EUDAMED
- Device Name
- Roeko Steel Matrix Band EUDAMED
- Model / Reference
- 591505 EUDAMED591506 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E2995915050 EUDAMED+E2995915060 EUDAMED
- Basic UDI-DI
- ++E299ROEKOSTEELMATRIXD8 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY 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 Steel matrix band soft 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 | ++E299ROEKOSTEELMATRIXD8 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-MF-000008779
- Authorised Representative
- IDD International Dental Distributors AG LI-AR-000008367
Sources (2)
- EUDAMED c240199e-7b35-4583-b8c8-a889b95e7db3 61 fields · synced Jul 25, 2026
- EUDAMED 86c163e5-b8b4-47d3-97db-a4cd9ff1ecdc 61 fields · synced May 19, 2026