Identity
- Trade Name
- Classic by RISKONTROL EUDAMEDFDA UDI
- Generic Name
- Surgical mist irrigation tip FDA UDI
- Device Name
- RISKONTROL tips EUDAMEDDisposable single use tips for air/water syringe. FDA UDI
- Model / Reference
- 201668 EUDAMEDRISKONTROL FDA UDI
- Description
- Disposable single use tips for air/water syringe. FDA UDI
Identifiers
- Catalog Number
- 201668 FDA UDI
- Primary DI / UDI-DI
- 03760243000539 EUDAMEDFDA UDI
- Basic UDI-DI
- 376024300riskontrolSH EUDAMED
- Unit of Use DI
- 03760243009952 EUDAMED
- FDA Product Code
- ECB FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical mist irrigation tip FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Classic by RISKONTROL by Acteon Manufacturing — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376024300riskontrolSH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (2)
- EUDAMED 19709e13-60ca-453e-a22b-77bc3c745349 61 fields · synced Jun 18, 2026
- FDA UDI 54f29f71-6ca4-4963-b44a-0f9a040b4afd 35 fields · synced May 30, 2026