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Ultra-Fine PRO Pen Needles
EUDAMEDClass IIa (EU MDR)
Ref 320566Model Pen NeedleRef 321125Ref 320571Ref 320561
Identity
- Trade Name
- Ultra-Fine PRO 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 EUDAMED320566 EUDAMED321125 EUDAMED320571 EUDAMED320561 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017056636 EUDAMED00383017112516 EUDAMED00383017057114 EUDAMED00383017056131 EUDAMED
- Basic UDI-DI
- 0383017LGPNNDLSCPVK EUDAMED
- Unit of Use DI
- 80383017056687 EUDAMED80383017112581 EUDAMED80383017057189 EUDAMED80383017056182 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 PRO 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 (4)
- EUDAMED ca60744b-2ddd-4375-bd0a-e459d11ad132 61 fields · synced Aug 2, 2026
- EUDAMED 5c54ba98-1ecb-4a39-b10a-5c48eb99b53a 61 fields · synced May 18, 2026
- EUDAMED b221fd09-b6bc-4d43-b93b-b499225e7a0f 61 fields · synced May 18, 2026
- EUDAMED c002bbd2-48ad-4fea-8701-240167435ed4 61 fields · synced May 18, 2026