Identity
- Trade Name
- Sterile by RISKONTROL EUDAMED
- Device Name
- RISKONTROL sterile tips EUDAMED
- Model / Reference
- 201770 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760243007019 EUDAMED
- Basic UDI-DI
- 376024300risksterileFS EUDAMEDB-03760243007019 EUDAMED
- Unit of Use DI
- 03760243000560 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile by RISKONTROL by Acteon Manufacturing — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 376024300risksterileFS | Class I | Active |
| EUDAMED | European Union | CE/MDR | 376024300risksterileFS | Class I | Active |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (2)
- EUDAMED 6ce03c55-d6f7-44e4-9a1a-ba64ebd7b4dc 61 fields · synced Sep 18, 2026
- EUDAMED d7e24775-6e7e-4f8f-bfbb-635089fa38f4 61 fields · synced May 17, 2026