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EZ-IO(R) 15mm Needle Set
EUDAMEDClass IIa (EU MDR)
Ref 9018-EU-005Model IPN917326
Identity
- Trade Name
- EZ-IO(R) 15mm Needle Set EUDAMED
- Device Name
- EZ-IO 15MM NEEDLE SET(BX/5) EU CONF EUDAMED
- Model / Reference
- IPN917326 EUDAMED9018-EU-005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10801902170382 EUDAMED
- Basic UDI-DI
- B-10801902170382 EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intraosseous infusion kit
EZ-IO(R) 15mm Needle Set by Teleflex Medical — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10801902170382 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical
- EUDAMED SRN
- IE-MF-000015868
Sources (1)
- EUDAMED 5b91d635-7343-41e5-802a-2b1e734025c4 61 fields · synced Jun 20, 2026