Identity
- Trade Name
- embecta Pen Needles EUDAMED
- Device Name
- Ultra-Fine; Nano; Micro-Fine; Ultra-Fine PRO; Micro-Fine PRO; Viva; Nano 2nd Gen; Base-Fine; embecta; EUDAMED
- Model / Reference
- Pen Needle EUDAMED321109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017110932 EUDAMED
- Basic UDI-DI
- 0383017LGPNNDLSCPVK EUDAMED
- Unit of Use DI
- 80383017110983 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
embecta Pen Needles by embecta Medical II LLC — 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 | 0383017LGPNNDLSCPVK | Class IIa | Active |
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Manufacturer
- Manufacturer
- embecta Medical II LLC
- EUDAMED SRN
- US-MF-000044225
- Authorised Representative
- embecta Penel Limited IE-AR-000040945
Sources (1)
- EUDAMED 1b7f417f-714c-4f0e-9fbf-4a9e015ff055 61 fields · synced Jun 19, 2026