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Ultra-Fine Pen Needles
EUDAMEDClass IIa (EU MDR)
Ref 320477Model Pen NeedleRef 320524Ref 320698Ref 320522Ref 320123Ref 320120Ref 320523
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 EUDAMED320477 EUDAMED320524 EUDAMED320698 EUDAMED320522 EUDAMED320123 EUDAMED320120 EUDAMED320523 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017047733 EUDAMED00383017052430 EUDAMED00383017069834 EUDAMED00383017052232 EUDAMED00383017012311 EUDAMED50383017012057 EUDAMED00383017052331 EUDAMED
- Basic UDI-DI
- 0383017LGPNNDLSCPVK EUDAMED
- Unit of Use DI
- 80383017047784 EUDAMED80383017052481 EUDAMED80383017069885 EUDAMED80383017052283 EUDAMED80383017012386 EUDAMED80383017012089 EUDAMED80383017052382 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 | 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 (7)
- EUDAMED 0e4f464d-18ab-4b07-a2da-4e7a32799b40 61 fields · synced Jul 26, 2026
- EUDAMED 87f47d1c-6ee8-4884-86ab-e3541f052937 61 fields · synced May 16, 2026
- EUDAMED c5cb7f48-a259-455e-81b5-d4f1073e040d 61 fields · synced May 17, 2026
- EUDAMED 37aeb915-ee18-4d40-9e9c-8c28ab02a7ed 61 fields · synced May 18, 2026
- EUDAMED 6e8f8c26-aa18-48b0-96c1-f360884d117c 61 fields · synced May 18, 2026
- EUDAMED 7f7f8807-6340-47ac-80e9-9b11ae9b7c2f 61 fields · synced May 18, 2026
- EUDAMED 29863fca-5d82-48fe-af90-2a77f796d5bc 61 fields · synced May 19, 2026