Identity
- Trade Name
- Ultra-Fine 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 EUDAMED329477 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017947736 EUDAMED
- Basic UDI-DI
- 383017LGPNNDLSCP EUDAMED0383017LGPNNDLSCPVK EUDAMED
- Unit of Use DI
- 80383017947787 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
Ultra-Fine 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 | 383017LGPNNDLSCP | 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 (2)
- EUDAMED 05310f41-d8c9-4b7b-a283-6244c245c122 61 fields · synced Jun 18, 2026
- EUDAMED 875f465f-e964-4ed1-adc0-184a97d2b4ca 61 fields · synced Jun 18, 2026