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Micro-Fine Ultra Pen Needles
EUDAMEDClass IIa (EU MDR)
Ref 320500Model Pen NeedleRef 325118Ref 325108Ref 320649Ref 320207Ref 320585Ref 320587Ref 321097
Identity
- Trade Name
- Micro-Fine Ultra 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 EUDAMED320500 EUDAMED325118 EUDAMED325108 EUDAMED320649 EUDAMED320207 EUDAMED320585 EUDAMED320587 EUDAMED321097 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017050030 EUDAMED00383017511838 EUDAMED00383017510831 EUDAMED00383017064914 EUDAMED00383017020736 EUDAMED00383017058531 EUDAMED00383017058739 EUDAMED00383017109738 EUDAMED
- Basic UDI-DI
- 0383017LGPNNDLSCPVK EUDAMED
- Unit of Use DI
- 80383017050081 EUDAMED80383017511889 EUDAMED80383017510882 EUDAMED80383017064989 EUDAMED80383017020787 EUDAMED80383017058582 EUDAMED80383017058780 EUDAMED80383017109789 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Micro-Fine Ultra 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 (9)
- EUDAMED 8ec26c91-4c5a-4b98-b151-d172ff2b9f64 61 fields · synced Jul 24, 2026
- EUDAMED 646afa92-9bdd-47f4-9c10-40a8a08ef3f8 61 fields · synced May 16, 2026
- EUDAMED b61be65b-f2c7-45b5-8ce5-848d75f2e1b7 61 fields · synced May 17, 2026
- EUDAMED ef12be34-6d5d-4714-a815-e85a5c7a3972 61 fields · synced May 17, 2026
- EUDAMED 74d09ce3-41b9-49a2-995d-440c995e61e6 61 fields · synced May 17, 2026
- EUDAMED 81480f6e-ccac-4dbe-80f4-f7863e09e9aa 61 fields · synced May 17, 2026
- EUDAMED 25a99db2-5c4c-4df8-859d-026020e1598f 61 fields · synced May 18, 2026
- EUDAMED da79f06d-27f4-4ae1-a9de-7c1eb9498992 61 fields · synced May 19, 2026
- EUDAMED 55cd191e-652d-4021-91bf-a78b3517a639 61 fields · synced Jul 15, 2026