roeko Stay-put / non-impregnated, fine (1), 183 cm
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- roeko Stay-put / non-impregnated, fine (1), 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 1 (fine) FDA UDI
- Model / Reference
- Retraction cords EUDAMED521001 EUDAMEDFDA UDI
- Description
- ROEKO Stay-put non-impregnated size 1 (fine) FDA UDI
Identifiers
- Catalog Number
- 521001 FDA UDI
- Primary DI / UDI-DI
- E1655210010 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, fine (1), 183 cm by Coltène/Whaledent GmbH + Co. KG — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041023 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++E165PRO1STPU4001DE | Class I | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (3)
- EUDAMED b371cebd-c627-4a20-a27c-3968beb5147a 61 fields · synced Oct 6, 2026
- FDA UDI defeeca4-15dd-47e8-965e-cbd56b920d3e 37 fields · synced May 26, 2026
- FDA 510(k) K041023 1 fields · synced May 18, 2026