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roeko Comprecap anatomic #1, 120 pcs
EUDAMEDClass I (EU MDR)
Ref 531201Model Comprecap
Identity
- Trade Name
- roeko Comprecap anatomic #1, 120 pcs EUDAMED
- Device Name
- roeko Comprecap EUDAMED
- Model / Reference
- Comprecap EUDAMED531201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E1655312011 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 anatomic #1, 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 6ce6d4e6-6b94-42a5-b83a-80b9fae5320d 61 fields · synced Jul 15, 2026