embecta Pen Needles
by embecta Medical II LLC 30 variants
Ref 321143Model Pen Needle
embecta Pen Needles (321143) is a Class IIa device made by embecta Medical II LLC, registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI 0383017BYNDPNNDLEONC), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0383017BYNDPNNDLEONC 00383017114336 | Date14 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 0383017BYNDPNNDLEONC
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- embecta Pen Needle
- Model / reference
- Pen Needle, 321143
- Primary DI / UDI-DI
- 00383017114336
- Basic UDI-DI
- 0383017BYNDPNNDLEONC
- Unit of use DI
- 80383017114387
- EMDN code
- A0101010202 Hypodermic pen needles, w/o safety systems
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- US-MF-000044225
- Authorised representative
- embecta Penel Limited IE-AR-000040945
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