roeko Stay-put / non-impregnated, thick (3), 183 cm
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- roeko Stay-put / non-impregnated, thick (3), 183 cm EUDAMEDROEKO Stay-put FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- roeko Stay-put EUDAMEDROEKO Stay-put non-impregnated size 3 (thick) FDA UDI
- Model / Reference
- Retraction cords EUDAMED521003 EUDAMEDFDA UDI
- Description
- ROEKO Stay-put non-impregnated size 3 (thick) FDA UDI
Identifiers
- Catalog Number
- 521003 FDA UDI
- Primary DI / UDI-DI
- E1655210030 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E165PRO1STPU4001DE EUDAMED
- 510(k) Number
- K041023 FDA UDI
- FDA Product Code
- MVL FDA UDI
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
- GMDN Term
- Gingival retraction cord, non-medicated FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Gingival retraction cord, non-medicated
roeko Stay-put / non-impregnated, thick (3), 183 cm by Coltène/Whaledent GmbH + Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Gingival retraction cord, non-medicated.
- R-101 — PASCAL COMPANY, INC. · Class I
- Smartcord 2 — EASTDENT Co., Ltd · 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
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
- Mouth Prop — Huanghua Promisee Dental Co.Ltd. · Class I
- Retraction wires & gingival retractors — CLINIMED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E165PRO1STPU4001DE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (2)
- EUDAMED 7973a208-1a48-44d0-af3f-8fdfb372ae65 61 fields · synced Jun 19, 2026
- FDA UDI f78a7bfb-8a0e-4ee8-a240-1e308ec1a73e 37 fields · synced May 30, 2026