Identity
- Trade Name
- RISKONTROL ENGLE EUDAMED
- Device Name
- RISKONTROL adapter EUDAMED
- Model / Reference
- 200194 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760243000102 EUDAMED
- Basic UDI-DI
- 376024300adaptateurTU EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Riskontrol Engle by Acteon Manufacturing — 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 | 376024300adaptateurTU | Class I | Active |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (1)
- EUDAMED 2f052eb2-5d3c-42b7-a2de-79d9817d43a0 61 fields · synced Jul 31, 2026