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AutoShield Duo Pen Needles
EUDAMEDClass IIa (EU MDR)
Ref 329535Model Safety Pen NeedleRef 329608
Identity
- Trade Name
- AutoShield Duo Pen Needles EUDAMEDAutoShield Duo Safety Pen Needles EUDAMED
- Device Name
- Autoshield Duo EUDAMED
- Model / Reference
- Safety Pen Needle EUDAMED329535 EUDAMED329608 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017953539 EUDAMED00383017960834 EUDAMED
- Basic UDI-DI
- 0383017SFPNASDNERYU EUDAMED
- Unit of Use DI
- 80383017953580 EUDAMED80383017960885 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMEDFrance 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
AutoShield Duo 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 | 0383017SFPNASDNERYU | 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 b1526b3b-aa3f-4760-92a2-126cfa6fadbb 61 fields · synced Jul 9, 2026
- EUDAMED 2b8838be-844a-4245-aea3-9d4d25fc4045 61 fields · synced May 18, 2026
- EUDAMED 3afc967c-cd7c-4fb2-8598-e458f97f65d2 61 fields · synced Jul 9, 2026
- EUDAMED 671041ac-3023-4e1d-9496-ddffbf744082 61 fields · synced Jul 9, 2026