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Dental rolls ROEKO Luna #1 500pcs
EUDAMEDClass I (EU MDR)
Ref 105001Model Dental Rolls
Identity
- Trade Name
- Dental rolls ROEKO Luna #1 500pcs EUDAMED
- Device Name
- ROEKO Luna EUDAMED
- Model / Reference
- Dental Rolls EUDAMED105001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14260538378320 EUDAMED
- Basic UDI-DI
- ++E165TAU1LUNA4001TL EUDAMED
- EMDN Code
- Q019004 DENTAL COTTON ROLLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Dental rolls ROEKO Luna #1 500pcs by Coltène/Whaledent GmbH + Co. KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++E165TAU1LUNA4001TL | Class I | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (1)
- EUDAMED 2a5a7a37-e73b-4329-98e7-54984ba93f75 61 fields · synced Jul 31, 2026