Identity
- Trade Name
- roeko Comprecap #3, 120 pcs EUDAMED
- Device Name
- roeko Comprecap EUDAMED
- Model / Reference
- Comprecap EUDAMED530010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E1655300101 EUDAMED
- Basic UDI-DI
- ++E165PRO1COCA4001LZ 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 Comprecap #3, 120 pcs 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 | ++E165PRO1COCA4001LZ | Class I | Active |
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Manufacturer
- Manufacturer
- Coltène/Whaledent GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005717
Sources (1)
- EUDAMED 6344bdab-80a1-4a86-991d-402b0e755a2a 61 fields · synced Jul 15, 2026