Identity
- Trade Name
- Ago 28GX 1/2"- PENTALANCE EUDAMED
- Device Name
- SIRINGHE CON AGO E AGHI IPODERMICI EUDAMED
- Model / Reference
- 004021M05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015262010027 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 28GX 1/2"- 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 68723282-c368-4a4c-acc1-535a1e493d24 61 fields · synced Jul 8, 2026