Identity
- Trade Name
- Ago 22GX 11/2"- PENTALANCE EUDAMED
- Device Name
- SIRINGHE CON AGO E AGHI IPODERMICI EUDAMED
- Model / Reference
- 004021E12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015262009779 EUDAMED
- Basic UDI-DI
- 80152621034S EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Ago 22GX 11/2"- PENTALANCE by Pentaferte Italia Srl — 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 | 80152621034S | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pentaferte Italia Srl
- EUDAMED SRN
- IT-MF-000040982
Sources (1)
- EUDAMED ba685e6e-4317-4b56-bfe7-71d116ca5008 61 fields · synced Jun 18, 2026