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roeko Retracto / braided / non-impregnated, fine (1), 225 cm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 511001Model Retraction cords
Identity
- Trade Name
- roeko Retracto / braided / non-impregnated, fine (1), 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 1 (fine) FDA UDI
- Model / Reference
- Retraction cords EUDAMED511001 EUDAMEDFDA UDI
- Description
- ROEKO Retracto Braided non-impregnated size 1 (fine) FDA UDI
Identifiers
- Catalog Number
- 511001 FDA UDI
- Primary DI / UDI-DI
- E1655110010 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
roeko Retracto / braided / non-impregnated, fine (1), 225 cm by Coltène/Whaledent GmbH + Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 0129b891-eb77-4a59-a611-746fd011f8ce 61 fields · synced Jun 18, 2026
- FDA UDI 6a6e39c4-4e8a-4440-9cb0-72a2a04e2cbc 37 fields · synced May 30, 2026