NephroNeedle
by Nephrocan Medi̇kal Sanayi̇ Ti̇caret Anoni̇m Şi̇rketi̇ 31 variants
Ref 4218420Model NephroNeedle16AVSR
NephroNeedle (4218420) is a Class IIa device made by Nephrocan Medi̇kal Sanayi̇ Ti̇caret Anoni̇m Şi̇rketi̇, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-868475920318PR), active as of 7 Nov 2026.
Active
CE MDD
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/MDD | NumberB-868475920318PR D-868475920318PR | Date6 Nov 2026 | StatusActive |
Official records
- EUDAMED public site B-868475920318PR
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Fistula Needle for Hemodialysis
- Model / reference
- NephroNeedle16AVSR, 4218420
- Primary DI / UDI-DI
- D-868475920318PR
- Basic UDI-DI
- B-868475920318PR
- EMDN code
- A010401 Arteriovenous fistula needles
- Device class
- Class IIa
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000046244
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