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Viva Pen Needles
EUDAMEDClass IIa (EU MDR)
Ref 321104Model Pen NeedleRef 320426Ref 321101
Identity
- Trade Name
- Viva 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 EUDAMED321104 EUDAMED320426 EUDAMED321101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017110437 EUDAMED10383017042612 EUDAMED00383017110130 EUDAMED
- Basic UDI-DI
- 0383017LGPNNDLSCPVK EUDAMED
- Unit of Use DI
- 80383017110488 EUDAMED80383017042680 EUDAMED80383017110181 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
Viva 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 (3)
- EUDAMED 3cb75243-5677-4633-905f-0b2069e42854 61 fields · synced Jul 20, 2026
- EUDAMED 0955ec2b-3efa-4406-b2ca-7b1f9603c4b7 61 fields · synced May 18, 2026
- EUDAMED 613047ae-7583-4e5e-9395-721393be20f7 61 fields · synced May 18, 2026