Identity
- Trade Name
- Flexi Nozzles (Long) EUDAMED
- Device Name
- Administration Kit EUDAMED
- Model / Reference
- FLX-ENT-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09333279000046 EUDAMED
- Basic UDI-DI
- 9333279FLEXINOZER EUDAMED
- EMDN Code
- A030499 ADMINISTRATION KITS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Flexi Nozzles (Long) by ENT Technologies Pty Ltd — 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 | 9333279FLEXINOZER | Class I | Active |
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Manufacturer
- Manufacturer
- ENT Technologies Pty Ltd
- EUDAMED SRN
- AU-MF-000050290
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (1)
- EUDAMED 4656a72d-e26a-4a3a-a9a7-db7f06b5897f 61 fields · synced Oct 6, 2026