Identity
- Trade Name
- Irriflex EUDAMEDFDA UDI
- Generic Name
- Dental irrigation/aspiration syringe FDA UDI
- Device Name
- Irriflex EUDAMEDIrriflex is a flexible cannula with radial opening for liquid ejection along the canal walls. FDA UDI
- Model / Reference
- 21400 EUDAMEDFDA UDI
- Description
- Irriflex is a flexible cannula with radial opening for liquid ejection along the canal walls. FDA UDI
Identifiers
- Catalog Number
- 21400 FDA UDI
- Primary DI / UDI-DI
- 07640159160113 EUDAMEDFDA UDI
- Basic UDI-DI
- 764015916CANNULASXW EUDAMED
- FDA Product Code
- EIC FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental irrigation/aspiration syringe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Irriflex by Produits Dentaires SA — Class IIa — 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 | 764015916CANNULASXW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (2)
- EUDAMED a345d81d-b970-4fde-8b46-706ec209b579 61 fields · synced Jul 23, 2026
- FDA UDI 1cb1313f-6b1b-46d0-b3d7-d27841fed26e 36 fields · synced May 29, 2026