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SafeAssist Pen Needles
EUDAMEDClass IIa (EU MDR)
Ref 329917Model Safety Pen NeedleRef 329916
Identity
- Trade Name
- SafeAssist Pen Needles EUDAMEDSafeAssist Safety Pen Needles EUDAMED
- Device Name
- SafeAssist EUDAMED
- Model / Reference
- Safety Pen Needle EUDAMED329917 EUDAMED329916 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017991739 EUDAMED00383017991630 EUDAMED
- Basic UDI-DI
- 0383017SFPNNLSAH43J EUDAMED
- Unit of Use DI
- 80383017991780 EUDAMED80383017991681 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDItaly 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
SafeAssist 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 | 0383017SFPNNLSAH43J | 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 df20cb27-0479-4f76-9bea-f85dd5f9aed6 61 fields · synced Jul 15, 2026
- EUDAMED a6540774-f627-412f-9364-9ea1464819b9 61 fields · synced May 17, 2026
- EUDAMED b6a98e08-5633-4804-a1ae-0b10b6c5f11e 61 fields · synced Jul 10, 2026
- EUDAMED 1fd432aa-f920-4953-aee2-1fb3273d7d2a 61 fields · synced Jul 15, 2026