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Dental rolls ROEKO Luna Gold # 3/300 g
EUDAMEDClass I (EU MDR)
Ref 109123Model Dental Rolls
Identity
- Trade Name
- Dental rolls ROEKO Luna Gold # 3/300 g EUDAMED
- Device Name
- ROEKO Luna Gold EUDAMED
- Model / Reference
- Dental Rolls EUDAMED109123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14260538378412 EUDAMED
- Basic UDI-DI
- ++E165TAU1LUGO4001VK 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 Gold # 3/300 g 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 | ++E165TAU1LUGO4001VK | Class I | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (1)
- EUDAMED 36d8696a-d642-4493-90fe-dbf063f9df57 61 fields · synced Jul 30, 2026