Identity
- Device Name
- Irriflex with Endostops EUDAMED
- Model / Reference
- 21401_stp EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640159163626 EUDAMED
- Basic UDI-DI
- 0764015916PPCANNULASE2 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The IrriFlex cannula/needle is intended for root canal irrigation during endodontic procedure for the treatment of dental infection or traumatic dental injury. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Irriflex with Endostops by Produits Dentaires SA — Class IIa — 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 | 0764015916PPCANNULASE2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-PR-000045775
Sources (1)
- EUDAMED 026824fe-cd7b-4a93-ae4a-d1d561123315 61 fields · synced Jun 19, 2026