roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm EUDAMEDROEKO Retracto FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- roeko Retracto EUDAMEDROEKO Retracto Braided non-impregnated size 0 (x-fine) FDA UDI
- Model / Reference
- Retraction cords EUDAMED511000 EUDAMEDFDA UDI
- Description
- ROEKO Retracto Braided non-impregnated size 0 (x-fine) FDA UDI
Identifiers
- Catalog Number
- 511000 FDA UDI
- Primary DI / UDI-DI
- E1655110000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E165PRO1RETO40014E 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 Retracto / braided / non-impregnated, x-fine (0), 225 cm by Coltène/Whaledent GmbH + Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E165PRO1RETO40014E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (2)
- EUDAMED 7ce878b1-115a-4ce3-a31a-f745401aebbf 61 fields · synced Jul 14, 2026
- FDA UDI ed8428ad-a3fb-4677-8f9b-ddd333ff306f 37 fields · synced May 30, 2026