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EZ-IO 25mm Needle + Stabilizer Kit
EUDAMEDClass IIa (EU MDR)
Ref 9001P-EU-005Model IPN923039
Identity
- Trade Name
- EZ-IO 25mm Needle + Stabilizer Kit EUDAMED
- Device Name
- EZ-IO 25MM NEEDLE + STABILIZER BX/5 EUDAMED
- Model / Reference
- IPN923039 EUDAMED9001P-EU-005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10816000013899 EUDAMED
- Basic UDI-DI
- B-10816000013899 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 25mm Needle + Stabilizer Kit 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-10816000013899 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical
- EUDAMED SRN
- IE-MF-000015868
Sources (1)
- EUDAMED ccc2f12f-5789-4243-be06-9069a59232ab 61 fields · synced Jul 12, 2026