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Roeko Steel matrix band
EUDAMEDClass I (EU MDR)
Ref 590505Ref 590306Ref 590305Ref 590507Ref 590307
Identity
- Trade Name
- Roeko Steel matrix band EUDAMED
- Device Name
- Roeko Steel Matrix Band EUDAMED
- Model / Reference
- 590505 EUDAMED590306 EUDAMED590305 EUDAMED590507 EUDAMED590307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E2995905050 EUDAMED+E2995903060 EUDAMED+E2995903050 EUDAMED+E2995905070 EUDAMED+E2995903070 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 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 |
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Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-MF-000008779
- Authorised Representative
- IDD International Dental Distributors AG LI-AR-000008367
Sources (5)
- EUDAMED ba0fe071-54fa-4080-890c-dd164bad12a2 61 fields · synced Aug 3, 2026
- EUDAMED 2fc18f66-a0d2-4668-9f5a-75819098085a 61 fields · synced May 18, 2026
- EUDAMED 46f0add2-7611-4498-8ee6-c7b64cabc0cb 61 fields · synced May 18, 2026
- EUDAMED 16c6f8d9-2f82-4d47-9166-0bcd0bc68c6e 61 fields · synced May 18, 2026
- EUDAMED eea35ce5-1d3f-43cf-9a16-9a3ff5b670b2 61 fields · synced May 18, 2026