Identity
- Trade Name
- R&S Retraction Cord EUDAMED
- Device Name
- Retraction Cord, Non-Impregnated EUDAMED
- Model / Reference
- 3110316 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069204577 EUDAMED
- Basic UDI-DI
- 880926429SC2P EUDAMED
- Direct Marketing DI
- 08800069204577 EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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: Gingival retraction cord, non-medicated
R&S Retraction Cord by Sure Dent Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
- R-101 — PASCAL COMPANY, INC. · Class I
- Smartcord 2 — EASTDENT Co., Ltd · Class I
- roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- Hilo de retracción tejido Nº2 Dentaflux — J RIPOLL SL · Class I
- Hilo de retracción tejido Nº00 Dentaflux — J RIPOLL SL · Class I
- Henry Schein — HENRY SCHEIN, INC. · U
- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · 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 | 880926429SC2P | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 045f6227-7d85-4c44-aae0-0d27ca069dfc 61 fields · synced Jul 8, 2026