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roeko Cotton pellets # 0, 4g
EUDAMEDClass I (EU MDR)
Ref 210110Model Cotton pellets
Identity
- Trade Name
- roeko Cotton pellets # 0, 4g EUDAMED
- Device Name
- roeko Cotton pellets EUDAMED
- Model / Reference
- Cotton pellets EUDAMED210110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E1652101101 EUDAMED
- Basic UDI-DI
- ++E165TAU1COPE4001M9 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
roeko Cotton pellets # 0, 4g 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 | ++E165TAU1COPE4001M9 | Class I | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (1)
- EUDAMED e5e9fa4a-793f-458a-97f9-8325afaf48a5 61 fields · synced Jun 18, 2026