← Back to catalogue
embecta Pen Needles
EUDAMEDClass IIa (EU MDR)
Ref 320157Model Pen NeedleRef 321105Ref 320120
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 EUDAMED320157 EUDAMED321105 EUDAMED320120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60383017015765 EUDAMED00383017110536 EUDAMED60383017012061 EUDAMED
- Basic UDI-DI
- 383017LGPNNDLSCP EUDAMED0383017LGPNNDLSCPVK EUDAMED
- Unit of Use DI
- 80383017015783 EUDAMED80383017110587 EUDAMED80383017012089 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 | 383017LGPNNDLSCP | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- embecta Medical II LLC
- EUDAMED SRN
- US-MF-000044225
- Authorised Representative
- embecta Penel Limited IE-AR-000040945
Sources (5)
- EUDAMED 812bd07d-f2a1-4da9-acb4-b02b787ebc5e 61 fields · synced Jul 29, 2026
- EUDAMED db7f63e8-1bff-46c8-b25d-f3e8d6c2cc4f 61 fields · synced May 17, 2026
- EUDAMED 4c5f99e2-1dcb-4915-90c8-a74ca295c29e 61 fields · synced May 17, 2026
- EUDAMED 04ecfee1-08ba-4196-8f5f-9741a74fb117 61 fields · synced Jun 20, 2026
- EUDAMED d53bf434-590b-43ee-b582-08c24caf0b2a 61 fields · synced Jul 17, 2026